Footwear and offloading interventions to prevent and heal foot ulcers

NewsBot · Apr 30, 2008

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The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review.
Bus SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlaváček P, Bakker K, Cavanagh PR.
Diabetes Metab Res Rev. 2008 Apr 29;24(S1):S162-S180 [Epub ahead of print]

BACKGROUND: Footwear and offloading techniques are commonly used in clinical practice for the prevention and treatment of foot ulcers in diabetes, but the evidence base to support this use is not well known. The goal of this review was to systematically assess the literature and to determine the available evidence on the use of footwear and offloading interventions for ulcer prevention, ulcer treatment, and plantar pressure reduction in the diabetic foot.

METHODS: A search was made for reports on the effectiveness of footwear and offloading interventions in preventing or healing foot ulcers or reducing plantar foot pressure in diabetic patients published prior to May 2006. Both controlled and uncontrolled studies were included. Assessment of the methodological quality of studies and data extraction was independently performed by two reviewers. Interventions were assigned into four subcategories: casting, footwear, surgical offloading and other offloading techniques.

RESULTS: Of 1651 articles identified in the baseline search, 21 controlled studies were selected for grading following full text review. Another 108 uncontrolled and cross-sectional studies were examined. The evidence to support the use of footwear and surgical interventions for the prevention of ulceration is meagre. Evidence was found to support the use of total contact casts and other non-removable modalities for treatment of neuropathic plantar ulcers. More studies are needed to support the use of surgical offloading techniques for ulcer healing. Plantar pressure reduction can be achieved by several modalities including casts, walkers, and therapeutic footwear, but the diversity in methods and materials used limits the comparison of study results.

CONCLUSIONS: This systematic review provides support for the use of non-removable devices for healing plantar foot ulcers. Furthermore, more high-quality studies are urgently needed to confirm the promising effects found in both controlled and uncontrolled studies of footwear and offloading interventions designed to prevent ulcers, heal ulcers, or reduce plantar pressure.
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Admin2 · Apr 30, 2008

Related threads:
Therapeutic footwear
Off Loading
Diabetic foot orthotics

NewsBot · Apr 24, 2011

Forefoot plantar pressure reduction of off-the-shelf rocker bottom provisional footwear.
Kavros SJ, Van Straaten MG, Coleman Wood KA, Kaufman KR.
Clin Biomech (Bristol, Avon). 2011 Apr 19. [Epub ahead of print]

BACKGROUND:
Increased plantar pressures have been shown to be a risk factor in ulceration of the neuropathic foot. Prescriptive footwear is a common medical treatment, yet evidence regarding the efficacy of these prescriptions is underdeveloped. The purpose of this study is to determine the off-loading properties of four provisional shoes; a rocker sole compared to a flat sole shoe with and without the addition of a 1.25cm plastizote insert.

METHODS:
Fifteen subjects with peripheral neuropathy and a normal longitudinal arch were recruited to compare four types of provisional (post-operative) footwear. Plantar surface foot pressures were measured while wearing a rocker sole shoe or a flat stiff sole shoe. Both shoes were worn with and without a 1.25cm plastizote insert. Peak plantar pressures were recorded for the hallux, metatarsal heads (1-5), midfoot, and heel.

FINDINGS:
The rocker sole shoe with plastizote had the best off-loading properties. While wearing this footwear, mean peak plantar pressure was 2.8kg/cm(2) (range: 1.7 to 4.5kg/cm(2), 50% mean reduction from flat sole shoe without plastizote) and 1.9kg/cm(2) (range: 0.7 to 3.6kg/cm(2), 35% mean reduction) at the five metatarsal heads and hallux, respectively.

INTERPRETATION:
For patients with a normal longitudinal arch and forefeet, either at risk of developing an ulcer or are healing a forefoot ulcer, a provisional shoe with a rocker sole and plastizote insole provides plantar pressure reduction of the forefoot. However, when results were analyzed for the subjects individually the amount of off-loading varied.
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NewsBot · Aug 24, 2012

Offloading effect of therapeutic footwear in patients with diabetic neuropathy at high risk for plantar foot ulceration.
Arts ML, Waaijman R, de Haart M, Keukenkamp R, Nollet F, Bus SA.
Diabet Med. 2012 Aug 22.

Aims: Custom-made therapeutic footwear is often prescribed to patients with diabetic neuropathy, foot deformity and a healed plantar foot ulcer. Offloading these feet is important to prevent ulcer recurrence. The aim was to evaluate the offloading effect of custom-made footwear in these patients.

Methods: In 171 patients with diabetic neuropathy (336 feet) with foot deformity and a recently healed plantar foot ulcer, plantar pressures walking barefoot and inside new custom-made footwear were measured. At the previous ulcer location and at locations of highest barefoot pressure attributable to the deformity, in-shoe pressures were compared with non-deformed feet. The footwear was considered effective in offloading when in-shoe peak pressure at these locations was < 200 kPa.

Results: Mean in-shoe peak pressures ranged between 211 and 308 kPa in feet with forefoot deformity (vs. 191-222 kPa in non-deformed feet) and between 140 and 187 kPa in feet with midfoot deformity (vs. 112 kPa in non-deformed feet). Offloading was effective in 61% of all feet with deformity, 81% of feet with midfoot deformity, 44% of feet with forefoot deformity and 62% of previous ulcer locations. Inter-subject variability in measured in-shoe plantar pressure was large.

Conclusions: Offloading of custom-made footwear is often not sufficiently achieved in high-risk diabetic feet with deformity. Highest offloading success rates were seen at known high-risk locations such as previous ulcer locations and Charcot feet, the lowest success rates in forefoot deformities. Together with the large inter-subject variability in pressure outcomes, this emphasizes the need for evidence-based prescription and evaluation procedures to assure adequate offloading.
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NewsBot · May 7, 2013

The effectiveness of footwear as an intervention to prevent or to reduce biomechanical risk factors associated with diabetic foot ulceration: A systematic review.
Healy A, Naemi R, Chockalingam N.
J Diabetes Complications. 2013 May 1.

AIM:
Footwear interventions are used within clinical practice in an effort to reduce ulcerations however the effectiveness of these interventions is unclear. The aim of this paper was to conduct a systematic review which examined the effectiveness of footwear as an intervention for prevention of diabetic foot ulcers or the reduction of biomechanical risk factors for ulceration and to discuss the quality and interpret the findings of research to date.

METHODS:
The CINAHL, Medline and Cochrane Register of Controlled Trials databases were searched with 12 articles identified for review.

RESULTS:
The majority of these studies were cross sectional and examined the effect of different footwear conditions on plantar pressure measurements. Factors which influenced study findings such as participant selection, measurement and analysis techniques, footwear design and compliance are discussed and recommendations for future studies are provided.

CONCLUSIONS:
No research to date has examined the effectiveness of footwear in preventing ulceration. Conflicting findings are reported on the effective of footwear interventions to prevent reulceration. While the use of rocker sole footwear and custom orthoses in plantar pressure reduction are supported in cross sectional studies, longitudinal studies are required to confirm their benefit.
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NewsBot · Jul 22, 2013

How Effective Is Orthotic Treatment in Patients with Recurrent Diabetic Foot Ulcers?
Maria Luz Gonzalez Fernandez,et al
J Am Podiatr Med Assoc 103(4): 281-290, 2013

Background: We assessed the efficacy of customized foot orthotic therapy by comparing reulceration rates, minor amputation rates, and work and daily living activities before and after therapy. Peak plantar pressures and peak plantar impulses were compared with the patients not wearing and wearing their prescribed footwear.

Methods: One hundred seventeen patients with diabetes were prescribed therapeutic insoles and footwear based on the results of a detailed biomechanical study and were followed for 2 years. All of the patients had a history of foot ulcers, but none had undergone previous orthotic therapy.

Results: Before treatment, the reulceration rate was 79% and the amputation rate was 54%. Two years after the start of orthotic therapy, the reulceration rate was 15% and the amputation rate was 6%. Orthotic therapy reduced peak plantar pressures in patients with reulcerations and in those without (P < .05), although a significant decrease in peak plantar impulses was achieved only in patients not experiencing reulceration. Sick leave was reduced from 100% to 26%.

Conclusions: Personalized orthotic therapy targeted at reducing plantar pressures by off-loading protects high-risk patients against reulceration. Treatment reduced the reulceration rate and peak plantar pressures, leading to patients’ return to work or other activities.
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NewsBot · Jul 30, 2013

The effect of removing plugs and adding arch support to foam based insoles on plantar pressures in people with diabetic peripheral neuropathy
Tung-Liang Lin, Huey-Min Sheen, Chin-Teng Chung, Sai-Wei Yang, Shih-Yi Lin, Hong-Ji Luo, Chung-Yu Chen, I-Cheng Chan, Hsu-Sheng Shih and Wayne Huey-Herng Sheu
Journal of Foot and Ankle Research 2013, 6:29 doi:10.1186/1757-1146-6-29

Background
Removable plug for patients with diabetic neuropathic feet to offload local plantar pressure. However, quantitative evidence of pressure reduction by means of plug removal is limited. The value of additional insole accessories, such as arch additions, has not been tested. The purpose of this study was to evaluate the effect of removing plugs from foam based insoles, and subsequently adding extra arch support, on plantar pressures.

Methods
In-shoe plantar pressure measurements were performed on 26 patients with diabetic neuropathic feet at a baseline condition, in order to identify the forefoot region with the highest mean peak pressure (MPP). This was defined as the region of interest (ROI) for plug removal.The primary outcome was measurement of MPP using the pedar(R) system in the baseline and another three insole conditions (pre-plug removal, post-plug removal, and post-plug removal plus arch support).

Results
Among the 26 ROIs, a significant reduction in MPP (32.3%, P<0.001) was found after removing the insole plugs. With an arch support added, the pressure was further reduced (9.5%, P<0.001). There were no significant differences in MPP at non-ROIs between pre-and post-plug removal conditions.

Conclusions
These findings suggest that forefoot plantar pressure can be reduced by removing plugs and adding arch support to foam-based insoles. This style of insole may therefore be clinically useful in managing patients with diabetic peripheral neuropathy.
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NewsBot · Apr 25, 2014

Prevention of Recurrent Foot Ulcers With Plantar Pressure-Based In-Shoe Orthoses: The CareFUL Prevention Multicenter Randomized Controlled Trial.
Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR.
Diabetes Care. 2014 Apr 23.

OBJECTIVETo assess the efficacy of in-shoe orthoses designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration.

RESEARCH DESIGN AND METHODSSingle-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion), or to study termination. Proportional hazards regression was used for analysis.

RESULTSThere was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study.

CONCLUSIONSWe conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses but they did not significantly reduce nonulcerative lesions.
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NewsBot · Jun 18, 2014

Diabetic Foot Ulcer Off-loading: The Gap Between Evidence and Practice. Data from the US Wound Registry.
Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA.
Adv Skin Wound Care. 2014 Jul;27(7):310-316.

OBJECTIVE::
To evaluate the practice of off-loading diabetic foot ulcers (DFUs) using real-world data from a large wound registry to better identify and understand the gap between evidence and practice.
DESIGN::
Retrospective, deidentified data were extracted from the US Wound Registry based on patient/wound characteristics, procedures performed, and at which clinic the DFU was treated.
SETTING::
96 clinics (23 from the United States and Puerto Rico) PATIENTS:: 11,784 patients; 25,114 DFUs MAIN OUTCOME MEASURES:: Healed/not healed, amputated, percent off-loading, percent use of total contact casting (TCC), infection rate MAIN RESULTS:: Off-loading was documented in only 2.2% of 221,192 visits from January 2, 2007, to January 6, 2013. The most common off-loading option was the postoperative shoe (36.8%) and TCC (16.0%). There were significantly more amputations within 1 year for non-TCC-treated DFUs compared with TCC-treated DFUs (5.2% vs 2.2%; P = .001). The proportion of healed wounds was slightly higher for TCC-treated DFUs versus non-TCC-treated DFUs (39.4% vs 37.2%). Infection rates were significantly higher for non-TCC-treated DFUs compared with TCC-treated DFUs (2.6 vs 1.6; P = 2.1 × 10). Only 59 clinics used TCC (61%); 57% of those clinics used traditional TCC, followed by TCC-EZ (36%). Among clinics using any type of TCC, 96.3% of the DFUs that did not receive TCC were "TCC-eligible" ulcers. Among clinics using "traditional" TCC systems, 1.4% of DFUs were treated with TCC, whereas clinics using TCC-EZ provided TCC to 6.2% of DFUs.
CONCLUSION::
Total contact casting is vastly underutilized in DFU wound care settings, suggesting that there is a gap in practice for adequate off-loading. New, easier-to-apply TCC kits, such as the TCC-EZ, may increase the frequency with which this ideal form of adequate off-loading is utilized.
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NewsBot · Sep 24, 2014

The Effectiveness of Footwear and other Removable Off-Loading Devices in the Treatment of Diabetic Foot Ulcers: a Systematic Review.
Healy A, Naemi R, Chockalingam N.
Curr Diabetes Rev. 2014 Sep 18.

Aim: To conduct a systematic review which examined the effectiveness of footwear and other removable off-loading devices as interventions for the treatment of diabetic foot ulcers or the alteration of biomechanical factors associated with ulcer healing and to discuss the quality and interpret the findings of research to date.

Methods: The CINAHL, Medline and Cochrane Register of Controlled Trials databases were searched with seventeen articles identified for review.

Results: Majority of the identified studies were randomised control trials which compared the ulcer healing rates of different footwear and other removable off-loading device interventions. Three categories of interventions were identified; 1) removable cast walkers (RCWs), 2) half or heel relief shoes and 3) therapeutic shoes. Most studies compared at least one intervention to a total contact cast (TCC). Factors which influenced study findings such as TCC application method, compliance, activity levels, and the footwear worn on the contralateral limb are discussed with recommendations for future studies provided.

Conclusion: Due to the lack of randomised controlled studies conducted in this area it is not currently possible to make strong conclusions on the interventions effectiveness. However, it appears the currently available therapeutic shoes were the least effective intervention followed by half or heel relief shoes. RCWs were found to be the most effective of the removable devices.
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NewsBot · Mar 13, 2015

Data-driven directions for effective footwear provision for the high-risk diabetic foot.
Arts ML, de Haart M, Waaijman R, Dahmen R, Berendsen H, Nollet F, Bus SA.
Diabet Med. 2015 Mar 12.

AIMS:
Custom-made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom-made footwear and aims to provide data-driven directions for the provision of effectively offloading footwear in clinical practice.
METHODS:
Eighty-five people with diabetic neuropathy and a recently healed plantar foot ulcer, who participated in a clinical trial on footwear effectiveness, had their custom-made footwear evaluated with in-shoe plantar pressure measurements at three-monthly intervals. Footwear was modified when peak pressure was ≥ 200 kPa. The effect of single and combined footwear modifications on in-shoe peak pressure at these high-pressure target locations was assessed.
RESULTS:
All footwear modifications significantly reduced peak pressure at the target locations compared with pre-modification levels (range -6.7% to -24.0%, P < 0.001). The metatarsal heads were most frequently targeted. Repositioning an existing (trans-)metatarsal pad in the shoe insole (-15.9% peak pressure relief), applying local cushioning to the insole (-15.0%) and replacing the insole top cover with Plastazote (-14.2%) were the most effective single modifications. Combining a new Plastazote top cover with a trans-metatarsal bar (-24.0% peak pressure relief) or with local cushioning (-22.0%) were the most effective combined modifications.
CONCLUSIONS:
In people with diabetic neuropathy and a recently healed plantar foot ulcer, significant offloading can be achieved at high-risk foot regions by modifying custom-made footwear. These results provide data-driven directions for the design and evaluation of custom-made footwear for high-risk people with diabetes, and essentially mean that each shoe prescribed should incorporate those design features that effectively offload the foot. This article is protected by copyright. All rights reserved.
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NewsBot · Sep 7, 2015

Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review.
Bus SA, van Deursen RW, Armstrong DG, Lewis J, Caravaggi CF, Cavanagh PR
Diabetes Metab Res Rev. 2015 Sep 5

Footwear and offloading techniques are commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. The goal of this systematic review is to assess the medical scientific literature on this topic to better inform clinical practice about effective treatment. We searched the medical scientific literature indexed in PubMed, EMBASE, CINAHL, and the Cochrane database for original research studies published since May 1st 2006 related to four groups of interventions: 1) casting; 2) footwear; 3) surgical offloading; and, 4) other offloading interventions. Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were assessed for methodological quality, and extracted key data was presented in evidence and risk of bias tables. Uncontrolled studies were assessed and summarized on a narrative basis. Outcomes are presented and discussed in conjunction with data from our previous systematic review covering the literature from before May 1st 2006. We included two systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias show the efficacy of therapeutic footwear that demonstrates to relief plantar pressure and is worn by the patient, in the prevention of plantar foot ulcer recurrence. Two meta-analyses show non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers. Due to the limited number of controlled studies, clear evidence on the efficacy of surgical offloading and felted foam is not yet available. Interestingly, surgical offloading seems more effective in preventing than in healing ulcers. A number of controlled and uncontrolled studies show that plantar pressure can be reduced by several conservative and surgical approaches. Sufficient evidence of good quality supports the use of non-removable offloading to heal plantar neuropathic forefoot ulcers and therapeutic footwear with demonstrated pressure relief that is worn by the patient to prevent plantar foot ulcer recurrence. The evidence base to support the use of other offloading interventions is still limited and of variable quality. The evidence for the use of interventions to prevent a first foot ulcer or heal ischemic, infected, non-plantar, or proximal foot ulcers is practically non-existent. High-quality controlled studies are needed in these areas.
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NewsBot · Oct 30, 2015

Pedobarographic and kinematic analysis in the functional evaluation of two post-operative forefoot offloading shoes
Paolo Caravaggi, Alessia Giangrande, Lisa Berti, Giada Lullini and Alberto Leardini
Journal of Foot and Ankle Research 2015, 8:59 doi:10.1186/s13047-015-0116-3

Background
Forefoot offloading shoes are special orthopaedic footwear designed to protect and unload the injured part of the foot after surgery and for conservative treatments.

The offloading action is often achieved by transferring plantar load to the rearfoot via rocker shoes with reduced contact area between shoe and ground. While these shoes are intended to be worn only for short periods, a compromise must be found between functionality and the risk of alterations in gait patterns at the lower limb joints. In this study, the pedobarographic, kinematic and kinetic effects of a traditional half-shoe and a double-rocker full-outsole shoe were compared to those of a comfortable shoe (control).

Methods
Ten healthy female participants (28.2 ? 10.0 years) were asked to walk in three different footwear conditions for the left/right foot: control/half-shoe, control/full-outsole, and control/control. Full gait analysis was obtained in three walking trials for each participant in each condition. Simultaneously a sensor insole system recorded plantar pressure in different foot regions. Normalized root-mean-square error, coefficient of determination, and frame-by-frame statistical analysis were used to assess differences in time-histories of kinematic and kinetic parameters between shoes.

Results
The half -shoe group showed the slowest walking speed and the shortest stride length. Forefoot plantar load was significantly reduced in the half-shoe (maximum force as % of Body Weight: half-shoe = 62.1; full-outsole = 86.9; control = 93.5; p < 0.001). At the rearfoot, mean pressure was the highest in the full-outsole shoe. At the ankle, sagittal-plane kinematics in the full-outsole shoe had a pattern more similar to control.

Conclusions
The half-shoe appears significantly more effective in reducing plantar load at the forefoot than a double-rocker full-outsole shoe, which is designed to reduce forefoot loading by using an insole with a thicker profile anteriorly as to maintain the foot in slight dorsiflexion. However, the half-shoe is also associated with altered gait spatio-temporal parameters, more kinematic modifications at the proximal lower limb joints and reduced propulsion in late stance.
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NewsBot · Jan 29, 2016

A method for subject-specific modelling and optimisation of the cushioning properties of insole materials used in diabetic footwear.
Chatzistergos PE, Naemi R, Chockalingam N.
Med Eng Phys. 2015 Jun;37(6):531-8

This study aims to develop a numerical method that can be used to investigate the cushioning properties of different insole materials on a subject-specific basis. Diabetic footwear and orthotic insoles play an important role for the reduction of plantar pressure in people with diabetes (type-2). Despite that, little information exists about their optimum cushioning properties. A new in-vivo measurement based computational procedure was developed which entails the generation of 2D subject-specific finite element models of the heel pad based on ultrasound indentation. These models are used to inverse engineer the material properties of the heel pad and simulate the contact between plantar soft tissue and a flat insole. After its validation this modelling procedure was utilised to investigate the importance of plantar soft tissue stiffness, thickness and loading for the correct selection of insole material. The results indicated that heel pad stiffness and thickness influence plantar pressure but not the optimum insole properties. On the other hand loading appears to significantly influence the optimum insole material properties. These results indicate that parameters that affect the loading of the plantar soft tissues such as body mass or a person's level of physical activity should be carefully considered during insole material selection.
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NewsBot · Jul 25, 2019

An integrative review of therapeutic footwear for neuropathic foot due to diabetes mellitus.
Igiri BE et al
Diabetes Metab Syndr. 2019 Mar - Apr;13(2):913-923

BACKGROUND:
Therapeutic footwear is built on a model of patient's foot, for people with diabetes suffering with neuropathy. Can the footwear helps to improve plantar pressure in neuropathic foot? This study focussed on available data on therapeutic footwear as an intervention for improving and offloading plantar pressure in neuropathic diabetic foot.

METHODS:
Relevant scientific literature in PubMed, Medline and Google Scholar published between 2000 and 2017 were searched. The keywords searched were therapeutic footwear, plantar pressure, neuropathic foot, rocker sole, ulcer healing and offloading of plantar pressure. Articles on randomized controlled trials, observational, cohort, feasibility and factorial studies were reviewed.

RESULTS:
One hundred and twenty five (125) articles were identified. The article comprised of 6 randomized controlled trials, 2 observational, 1 cohort, 1 feasibility and 1 factorial study met the inclusion criteria and were critiqued with a total enrolment of 1380 study subjects.

CONCLUSIONS:
The review of the collated literature demonstrated that, therapeutic footwear can improve the healing of neuropathic diabetic foot ulcer by redistributing plantar pressure. However, the efficacy of therapeutic footwear requires the inclusion of technical features that should not be compromised from the design to the production of the footwear.
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NewsBot · Aug 18, 2020

Contact Pressures Between the Rearfoot and a Novel Offloading Insole: Results From a Finite Element Analysis Study
Seth T Strayer et al
J Appl Biomech. 2020 Jul 31;1-8

Pressure offloading is critical to diabetic foot ulcer healing and prevention. A novel product has been proposed to achieve this offloading with an insole that can be easily modified for each user. This insole consists of pressurized bubbles that can be selectively perforated and depressurized to redistribute weight to the nonulcer region of the foot. However, the effect of the insole design parameters, for example, bubble height and stiffness, on offloading effectiveness is unknown. To this end, a 3-dimensional finite element model was developed to simulate contact between the rearfoot and insole. The geometry of the calcaneus bone and soft tissue was based on the medical images of an average male patient, and material properties and loading conditions based on the values reported in the literature were used. The model predicts that increasing bubble height and stiffness leads to a more effectively offloaded region. However, the model also predicts that increasing stiffness leads to increasing contact pressures on the surrounding soft tissue. Thus, a combination of insole design parameters was determined, which completely offloads the desired region, while simultaneously reducing the contact pressure on the surrounding soft tissue. This design is expected to aid in diabetic foot ulcer healing and prevention.
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NewsBot · Aug 29, 2020

Fit for purpose? Footwear for patients with and without diabetic peripheral neuropathy: A cross-sectional study
Esther Chicharro-Luna et al
Clinical Biomech: August 27, 2020

Highlights
•The use of inappropriate footwear heightens local mechanical repetitive stresses on the foot in patients with DM.
•Accurate measurement of foot and shoe length is necessary to ensure a correct fit.
•Many diabetic patients do not wear correctly-fitting shoes, which increases their risk of foot ulcer.
•Assessing footwear for fit, in primary health care and podiatry clinics, reduces the risk of foot injury.
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Aim
This paper determines whether patients with and without Diabetic Peripheral Neuropathy use suitable footwear, taking into account that these persons are subject to a significant loss of sensitivity in the feet.
Methods
Cross-sectional observational study was conducted of 108 participants with diabetes mellitus. Inclusion criteria were at least five years’ progression of diabetes, the ability to walk unaided and no distal amputation of the foot. The presence of DPN was evaluated according to the criteria of the International Working Group on the Diabetic Foot. Foot length was measured using a Brannock® device and internal shoe length was determined using a CEGI® pedometer.
Results
In relation to adjustment, 21.6% of the shoes examined had no type of closure. The most common form of closure was laces, which were used in 32.4% of the shoes. 92.5% of footwear had internal seams. No significant relationship was found between the presence or otherwise of DPN and the use of appropriate shoe closure (p = 0.304), recommended heel height (p = 0.18), leather material (p = 0.77) and absence of internal seams (p = 0.759).
Conclusions
The majority of our participants living with DPN do not wear fitting shoes. Therefore, it is advisable to evaluate their use of footwear, both in primary health care and in podiatry clinics, to forestall potential complications.
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NewsBot · Sep 21, 2020

Plantar pressure distribution and wearing characteristics of three forefoot offloading shoes in healthy adult subjects
M.C.H.W.Fuchs et al
The Foot; 9 September 2020, 101744

Highlights
•Effect of forefoot offloading shoes was addressed in healthy participants.
•Wedge shoes showed the highest pressure reduction in the forefoot.
•The rocker shoe scored most positive on wearing characteristics
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Forefoot offloading shoes are used to reduce pressure on specific regions of the foot. Aim of the pressure reduction is to aid healing of the soft and bony tissues and prevent complications by treating foot disorders. A great variety of forefoot offloading shoes are available. In a first step to investigate the appropriate use of these footwear in orthopaedic settings, we studied plantar pressure distribution and wearing characteristics of three forefoot offloading shoes namely the Mailand, OrthoWedge and Podalux in a healthy population.

Twenty subjects walked in a randomized order wearing three forefoot offloading shoes and a reference shoe for six minutes. The Pedar system was used to measure the pressure in 7 regions. Peak pressure and pressure time integral were analyzed as measures of pressure distribution. Furthermore, wearing characteristics were addressed using a Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes were compared to a reference shoe.

The Mailand and OrthoWedge shoes significantly reduced peak pressure with more than 80% under the hallux and more than 45% under MTH1(p < .001). The Podalux did not show significant peak pressure reduction under the forefoot compared to the reference shoe. Under the lesser toes, the MTH4-5 region and heel region the Podalux shoe showed even a significant increase in peak pressure (p=.001). Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes(p < .01).

In this study we showed differences between different forefoot offloading shoes. The Mailand and OrthoWedge shoes gave the best pressure reduction in the forefoot but are less comfortable in use. The Podalux rocker shoe showed opposite results. Next step is a patient study to compare our results in a patient population.
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NewsBot · Apr 18, 2021

Effect of a carbon reinforcement for maximizing shoe outsole bending stiffness on plantar pressure and walking comfort in people with diabetes at high risk of foot ulceration
Jennefer B J Zwaferink et al
Gait Posture. 2021 Apr 9;86:341-345

Background: Different shoe design features can reduce peak plantar pressure to help prevent foot ulcers in people with diabetes. A carbon reinforcement of the shoe outsole to maximize bending stiffness is commonly applied in footwear practice, but its effect has not been studied to date.

Research question: What is the effect of a carbon shoe-outsole reinforcement on peak plantar pressure and walking comfort in people with diabetes at high risk of foot ulceration?

Methods: In 24 high-risk people with diabetes, in-shoe regional peak pressures were measured during walking at a comfortable speed in two different shoe conditions: an extra-depth diabetes-specific shoe with a non-reinforced outsole and the same type of shoe with a 3-mm-thick full-length carbon reinforcement of the outsole. The same custom-made insole was worn in both shoe conditions. Walking comfort was assessed using a Visual Analogue Scale (0-10, 10 being highest possible comfort).

Results: Significantly lower metatarsal head peak pressures (by a median 10-22 kPa) were found with the reinforced shoe compared to the non-reinforced shoe (p < .001). In >83% of cases with the reinforced shoe and >71% with the non-reinforced shoe metatarsal head peak pressures were <200 kPa. At the hindfoot, peak pressures were significantly higher (by a median 24 kPa) with the reinforced shoe (p = .001). No significant shoe effects were found for the toes. No significant shoe effects were found for walking comfort: median 6.1 for the reinforced shoe versus 5.6 for the non-reinforced shoe.

Significance: Adding a full-length carbon reinforcement to the outsole of a diabetes-specific shoe significantly reduces peak pressures at the metatarsal heads, where ulcers often occur, in high-risk people with diabetes, and this does not occur at the expense of patient-perceived walking comfort.
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NewsBot · Jul 25, 2021

Finite Element Analysis of Cushioned Diabetic Footwear Using Ethylene Vinyl Acetate Polymer
Mariyam J Ghazali et al
Polymers (Basel). 2021 Jul 9;13(14):2261

With the development of societies, diabetic foot ulcers have become one of the most common diseases requiring lower extremity amputation. The early treatment and prevention of diabetic foot ulcers can considerably reduce the possibility of amputation. Using footwear to redistribute and relieve plantar pressure is one of the important measures for the treatment and prevention of diabetic foot ulcers. Thus, the evaluation and prediction of the distribution of plantar pressure play an important role in designing footwears. Herein, the finite element method was used to study plantar pressure under two kinds of foot models, namely, the skeletal structure foot model and the whole foot model, to explore the influence of human bones on the pressure of the soles of the feet and obtain accurate foot pressure. Simulation results showed that under the two models, the plantar pressure and the pressure from the footwear with ethylene vinyl acetate were all reduced. The total deformation demonstrated a slight increase. These stresses are very useful as they enable the design of suitable orthotic footwear that reduces the amount of stress in individuals with diabetic foot ulcers.
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NewsBot · Aug 23, 2021

Footwear innovations for people with the
diabetic foot with ergonomic design
Hanieh Abdi1 et al
Source

Background: The foot is one of the organs of the body that have a major role in health, especially in
diabetics. During the day, a lot of pressure is transmitted through the legs to the knee, pelvis, and
spine, and any motivation in the shoe may put pressure on the gait parameters. Shoes should be
such that diabetics can feel comfortable enough and also not suffer from neuropathy or ulcers
caused by wearing them after work.
Method: In this study, 5 types of shoes available in the market that are offered as medical shoes
were selected and compared with quality ergonomic indicators. In the second stage, the effect of
these shoes for wearing for a long time was evaluated, and also the ratio of increase and comfort of
the person in the sole of the feet and knees was examined.
Results: Only one of the shoes had relatively good conditions for people with diabetes, which by
adding new items such as choosing the right fabric for ventilation of the foot area, considering the
appropriate anthropometric measurements in the toe area for more comfort, and having a suitable
insole to prevent the occurrence of musculoskeletal disorders in the lumbar region could be
sufficient.
Conclusion: In general, a design framework with specific tools is provided to have the right shoes
for the proper use of diabetics in the long run. Further research should focus on outsole design tools
and other shoe components.
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NewsBot · Jan 24, 2022

Custom-Molded Offloading Footwear Effectively Prevents Recurrence and Amputation, and Lowers Mortality Rates in High-Risk Diabetic Foot Patients: A Multicenter, Prospective Observational Study
Zhang X, Wang H, Du C, Fan X, Cui L, Chen H, Deng F, Tong Q, He M, Yang M, Tan X, Li L , Liang Z, Chen Y, Chen D, Armstrong DG, Deng W
10 January 2022

Background: Recurrence of high-risk diabetic feet, after wound, healing is a common challenge among diabetic patients. Continuous use of an offloading device significantly prevents recurrence of high-risk diabetic feet, although patient adherence is imperative to ensuring this therapy’s clinical efficacy. In this study, we explored clinical outcomes of patients with a high-risk diabetic foot who had been prescribed with custom-molded offloading footwear under different adherence conditions.
Methods: A total of 48 patients (17 females and 31 males) with high-risk diabetic feet, who had been with prescribed offloading footwear in 13 medical centers across 4 cities, were enrolled in the current study. The patients were assigned into either continuous offloading therapy (COT, n = 31) or interrupted offloading therapy (IOT, n = 17) groups, according to their adherence to the therapy. All patients were followed up monthly, and differences in recurrence, amputation, and deaths between the groups were analyzed at 4 months after therapy.
Results: Forty-eight patients met our inclusion criteria and were therefore included in the final analysis. Among them, 31 were stratified into the COT group and adhered to offloading therapy throughout the study period, whereas 17 were grouped as IOT and exhibited interrupted adherence to offloading therapy. We found statistically significant differences in recurrence rates (0 vs 38.46%, p < 0.01), amputation (0 vs 11.76%, p < 0.01), and deaths (0% vs 5.88%, p < 0.01) between the groups during follow-up.
Conclusion: Patients’ adherence is imperative to efficacy of custom-molded offloading footwear during treatment of high-risk diabetic foot. Further studies are needed to elucidate the role of improved design of the offloading device and the need for enhanced patient education for improved adherence.
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NewsBot · Jan 26, 2022

Impact of custom-made orthopedic footwear and plantar orthoses on quality of life and functionality of patients with diabetic neuropathic foot: A randomized clinical trial
MartaBotelho et al
Diabetes Epidemiology and Management; Volume 5, January–March 2022, 100040

Aims
Determine the effectiveness of custom-made orthopedic footwear (OF) and total contact plantar orthoses (PO) on the quality of life (QoL) and functionality of people with type 2 diabetes with diabetic peripheral neuropathic (DPN).

Methods
Randomized clinical study with 2 parallel intervention groups and pre- and post-test analysis. In the standard footwear group (SFg), PO and education on foot self-care were applied and in the orthopedic footwear group (OFg) the same intervention was applied, but with personalized OF. A total of 43 type 2 diabetic patients with DPN aged 61 – 76 years were randomized: 20 in to SFg and 23 to OFg.

Michigan Neuropathy Screening Instrument (MNSI) was used to screen for DPN. QoL was assessed with Short Form–36 and functional level was evaluated by Lower Extremity Functional Scale (LEFS), 6 physical tests and center of pressure (CoP) oscillation.

Results
No differences in QoL were found between groups. OFg showed a better functional reach and mediolateral displacement of CoP (p ≤ 0.05).

Conclusions
The OF does not show evidence on functional and QoL improvement in low-risk type 2 diabetic patients with neuropathy but both groups improved significantly in functional tests. The PO showed clinical value in these patients, so a regular and specialized treatment with appropriate footwear and plantar orthoses can play an important role in reducing the complications of diabetic neuropathy.
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NewsBot · Jan 26, 2022

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients
Catherine Park, PhD, Ramkinker Mishra, PhD, Davide Vigano, BS, ...
January 20, 2022

Background:
A critical factor in healing diabetic foot ulcers is patient adherence to offloading devices. We tested a smart offloading boot (SmartBoot) combined with a smartwatch app and cloud dashboard to remotely monitor patient adherence and activity. In addition, the impact of SmartBoot on balance, gait, and user experience was investigated.

Methods:
Fourteen volunteers (31.6±8.7 years; 64% female) performed natural activities (eg, sitting, standing, walking) with and without the SmartBoot for approximately 30 minutes. All participants completed balance tests, 10-meter walking tests at slow, normal, and fast pace while wearing the SmartBoot, and a user experience questionnaire. The accuracy of real-time adherence reporting was assessed by comparing the SmartBoot and staff observation. Center of mass (COM) sway and step counts were measured using a validated wearable system.

Results:
Average sensitivity, specificity, and accuracy for adherence and non-adherence were 90.6%, 88.0%, and 89.3%, respectively. The COM sway area was significantly smaller with the SmartBoot than without the SmartBoot regardless of test condition. Step count error was 4.4% for slow waking, 36.2% for normal walking, 16.0% for fast walking. Most participants agreed that the SmartBoot is easy to use, relatively comfortable, nonintrusive, and innovative.

Conclusions:
To our knowledge, this is the first smart offloading system that enables remote patient monitoring and real-time adherence and activity reporting. The SmartBoot enhanced balance performance, likely due to somatosensory feedback. Questionnaire results highlight SmartBoot’s technical and clinical potential. Future studies warrant clinical validation of real-time non-adherence alerting to improve wound healing outcomes in people with diabetic foot ulcers.
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NewsBot · Feb 1, 2022

Custom-Molded Offloading Footwear Effectively Prevents Recurrence and Amputation, and Lowers Mortality Rates in High-Risk Diabetic Foot Patients: A Multicenter, Prospective Observational Study
Xi Zhang et al
Diabetes Metab Syndr Obes. 2022 Jan 10

Background: Recurrence of high-risk diabetic feet, after wound, healing is a common challenge among diabetic patients. Continuous use of an offloading device significantly prevents recurrence of high-risk diabetic feet, although patient adherence is imperative to ensuring this therapy's clinical efficacy. In this study, we explored clinical outcomes of patients with a high-risk diabetic foot who had been prescribed with custom-molded offloading footwear under different adherence conditions.

Methods: A total of 48 patients (17 females and 31 males) with high-risk diabetic feet, who had been with prescribed offloading footwear in 13 medical centers across 4 cities, were enrolled in the current study. The patients were assigned into either continuous offloading therapy (COT, n = 31) or interrupted offloading therapy (IOT, n = 17) groups, according to their adherence to the therapy. All patients were followed up monthly, and differences in recurrence, amputation, and deaths between the groups were analyzed at 4 months after therapy.

Results: Forty-eight patients met our inclusion criteria and were therefore included in the final analysis. Among them, 31 were stratified into the COT group and adhered to offloading therapy throughout the study period, whereas 17 were grouped as IOT and exhibited interrupted adherence to offloading therapy. We found statistically significant differences in recurrence rates (0 vs 38.46%, p < 0.01), amputation (0 vs 11.76%, p < 0.01), and deaths (0% vs 5.88%, p < 0.01) between the groups during follow-up.

Conclusion: Patients' adherence is imperative to efficacy of custom-molded offloading footwear during treatment of high-risk diabetic foot. Further studies are needed to elucidate the role of improved design of the offloading device and the need for enhanced patient education for improved adherence.
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NewsBot · Jul 3, 2022

Predictive value of forefoot plantar pressure to predict reulceration in patients at high risk
MartaGarcía-MadridYolandaGarcía-ÁlvarezIreneSanz-CorbalánFrancisco J.Álvaro-AfonsoMateoLópez-MoralJosé LuisLázaro-Martínez
Diabetes Research and Clinical Practice; Volume 189, July 2022, 109976

Aims
To analyze a plantar pressure cut-off point for diabetic foot reulceration beneath the metatarsal heads in patients with previous forefoot amputation.

Methods
A one-year prospective study was conducted in a total of 105 patients at high risk for foot ulceration. Peak plantar pressure (PPP) and pressure-time integral (PTI) in the entire foot, the forefoot region, and each metatarsal head separately were registered. ROC curves were used to select the optimal diagnostic pressure cut-off points. Patients were follow-up monthly or until the development of an ulcer event.

Results
A total of 52 (49.5%) patients developed a reulceration. Using ROC analyses for PPP in the full-foot and in the forefoot, did not predict reulceration beneath the metatarsal heads. Analyzing separately each metatarsal head all patients with values greater than or equal to 20.8 N/cm2 at the 1st, 18.62 N/cm2 for the 2nd, 18.85 at the 3rd, 17.88 at the 4th, and 12.2 at the 5th metatarsal heads will suffer a reulceration despite the use of orthopedic treatment with optimum values of sensitivity (from 100 to 87.5) and specificity (from 83.2 to 62.8).

Conclusion
Barefoot pressures beneath the metatarsal heads should be analyzed separately to predict the region at risk of reulceration.
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NewsBot · Oct 10, 2022

Effects of Special Therapeutic Footwear on the Prevention of Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Bo Luo et al
J Diabetes Res. 2022 Sep 26

Objective: To reduce diabetic foot ulcer (DFU) occurrence or recurrence, diabetic therapeutic footwear is widely recommended in clinical practice for at-risk patients. However, the effectiveness of therapeutic footwear is controversial. Thus, we performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to examine whether special therapeutic footwear could reduce the incidence of DFU.

Method: We systematically searched multiple electronic databases (Medline, EMBASE, and EMB databases) to identify eligible studies published from inception to June 11, 2021. The database search, quality assessment, and data extraction were independently performed by two reviewers. Efficacy (i.e., incidence of DFU) was explored using the R'meta' package (version 4.15-1). To obtain more robust results, the random-effects model and the Hartung-Knapp-Sidik-Jonkman method were selected to assess pooled data. Metaregression analysis and sensitivity analysis were performed to explore heterogeneity, and publication bias was assessed by a visual inspection of funnel plots and the AS-Thompson test.

Results: Eight RCTs with a total of 1,587 participants were identified from the search strategy. Compared with conventional footwear, special therapeutic footwear significantly reduced the incidence of DFU (RR 0.49; 95% CI, 0.28-0.84), with no evidence of publication bias (P = 0.69). Unexpectedly, the effectiveness of special therapeutic footwear had a reverse correlation with the intervention time (coefficient = 0.085, P < 0.05) in the metaregression analysis.

Conclusion: Special therapeutic footwear with offloading properties is effective in reducing the incidence of DFU. However, the effect may decrease gradually over time. Despite undefined reasons, the optimal utility time and renewal frequency of special therapeutic footwear should be considered.
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NewsBot · Nov 28, 2022

Orthotic approach to prevention and management of diabetic foot: A narrative review
Min Cheol Chang et al
World J Diabetes. 2022 Nov 15;13(11):912-920.

Diabetic foot is a common complication affecting more than one-fifth of patients with diabetes. If not treated in time, it may lead to diabetic foot ulcers or Charcot arthropathy. For the management of diabetic foot, shoe modifications and orthoses can be used to reduce pressure on the affected foot or provide the foot with increased stability. In addition, the shoe modifications and orthotic devices can relieve patient discomfort during walking. Appropriate shoe modifications include changing the insole material, modifying the heel height, adding a steel shank or rocker sole, and using in-depth shoes. Alternatively, a walking brace or ankle-foot orthosis can be used to reduce the pressure on the affected foot. The purpose of this narrative review was to provide a reference guide to support clinicians in prescribing shoe modifications and foot orthoses to treat diabetic foot ulcers and Charcot arthropathy.
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NewsBot · Jan 16, 2023

Factors influencing the use of therapeutic footwear in persons with diabetes mellitus and loss of protective sensation: A focus group study
Athra Malki et al
PLoS One. 2023 Jan 12;18(1)

Background: Persons with diabetes mellitus (DM) and loss of protective sensation (LOPS) due to peripheral neuropathy do not use their therapeutic footwear (TF) consistently. TF is essential to prevent foot ulceration. In order to improve compliance in using TF, influencing factors need to be identified and analyzed. Persons with a history of foot ulceration may find different factors important compared with persons without ulceration or persons who have never used TF. Therefore, the objective of this study was to determine factors perceived as important for the use of TF by different groups of persons with DM and LOPS.

Method: A qualitative study was performed using focus group discussions. Subjects (n = 24) were divided into 3 focus groups based on disease severity: ulcer history (HoU) versus no ulcer history (no-HoU) and experience with TF (TF) versus no experience (no-TF). For each group of 8 subjects (TF&HoU; TF&no-HoU; no-TF&no-HoU), an online focus group discussion was organized to identify the most important influencing factors. Transcribed data were coded with Atlas.ti. The analysis was performed following the framework approach.

Results: The factors comfort and fit and stability/balance were ranked in the top 3 of all groups. Usability was ranked in the top 3 of group-TF&noHoU and group-noTF&noHoU. Two other factors, reducing pain and preventing ulceration were ranked in the top 3 of group-TF&noHoU and group-TF&HoU, respectively.

Conclusion: Experience with TF and a HoU influence which factors are perceived as important for TF use. Knowledge of these factors during the development and prescription process of TF may lead to increased compliance. Although the main medical reason for TF prescription is ulcer prevention, only 1 group gave this factor a high ranking. Therefore, next to focusing on influencing factors, person-centered education on the importance of using TF to prevent ulcers is also required.
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NewsBot · Feb 19, 2023

A three step protocol for the development of an innovative footwear (shoe and sensor based insole) to prevent diabetic foot ulceration
Liliana B Sousa et al
Front Public Health. 2023 Jan 30;11:1061383

Background: The incidence of diabetic foot ulceration (DFU) is increasing worldwide. Therapeutic footwear is usually recommended in clinical practice for preventing foot ulcers in persons with diabetes. The project Science DiabetICC Footwear aims to develop innovative footwear to prevent DFU, specifically a shoe and sensor-based insole, which will allow for monitoring pressure, temperature, and humidity parameters.

Method: This study presents a three-step protocol for the development and evaluation of this therapeutic footwear, specifically: (i) a first observational study will specify the user requirements and contexts of use; (ii) after the design solutions were developed for shoe and insole, the semi-functional prototypes will be evaluated against the initial requirements; (iii) and a pre-clinical study protocol will enable the evaluation of the final functional prototype. The eligible diabetic participants will be involved in each stage of product development. The data will be collected using interviews, clinical evaluation of the foot, 3D foot parameters and plantar pressure evaluation. This three-step protocol was defined according to the national and international legal requirements, ISO norms for medical devices development, and was also reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing (UICISA: E) of the Nursing School of Coimbra (ESEnfC).

Results: The involvement of end-users (diabetic patients) will enable the definition of user requirements and contexts of use to develop design solutions for the footwear. Those design solutions will be prototyped and evaluated by end-users to achieve the final design for therapeutic footwear. The final functional prototype will be evaluated in pre-clinical studies to ensure that the footwear meets all the requirements to move forward to clinical studies.

Discussion: The three-step study outlined in this protocol will provide the necessary insights during the product development, ensuring this new therapeutic footwear's main functional and ergonomic features for DFU prevention.
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NewsBot · May 4, 2023

A Scoping Review of Footwear Worn by People With Diabetes in Low- and Middle-Income Countries: Implications for Ulcer Prevention Programs
Madison Reddie et al
Glob Health Sci Pract. 2023 Apr 28;11(2):e2200392

International guidelines advise people with diabetes to wear close-toed, thick-soled footwear to protect against foot ulceration. However, this type of footwear is incompatible with some of the cultures, climates, and socioeconomic conditions in many low- and middle-income countries (LMICs). This scoping review aims to summarize what is known about footwear used by people with diabetes in LMICs and consider whether international diabetic foot guidelines are practical and actionable in these contexts, given current practices. PubMed, CINAHL, Scopus, Embase, Web of Science, Latin American and Caribbean Health Sciences Literature, and African Journals Online were searched for articles that documented the footwear used by people with diabetes in LMICs. Twenty-five studies from 13 countries were eligible for inclusion and indicated that a large proportion of people with diabetes wear footwear that is considered inappropriate by current guidance, with sandals and flip-flops being popular choices in a majority of the studies. Reasons given for these choices include poverty, lack of awareness of and provider communication about the importance of footwear selection, comfort, and cultural norms. We recommend that LMIC health care systems relying on international guidelines critically consider whether their recommendations are sensible in their settings. Diabetic foot experts and LMIC-based health care stakeholders should collaborate to design alternative guidelines, strategies, and interventions specifically for LMIC contexts to increase preventative practice feasibility and uptake.
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NewsBot · Aug 12, 2023

The effect of therapeutic footwear on the recurrence and new formation of foot ulcers in previously affected diabetic patients in Jeddah, Saudi Arabia
Maram T Alkhatieb et al
J Tissue Viability. 2023 Aug;32(3):417-422

Aim: Diabetic foot ulcers (DFUs), which are a common serious complication of diabetes mellitus, (lifetime occurrence, 19%-34%) account for at least 85% of all lower-limb amputations in diabetic patients. Special footwear (therapeutic footwear) is frequently recommended for such patients to adapt to changes in their foot structure. We aimed to, measure the effect of therapeutic footwear on DFU development and recurrence among previously affected patients in Saudi Arabia.

Materials and methods: A cross-sectional study was performed between June and September 2022. The study targeted patients aged ≥18 years previously diagnosed with DFU. Participants were contacted by telephone to complete a questionnaire assessing footwear use and foot care.

Results: This study included 115 participants with a mean age of 61.9 ± 11.63; overall, 47% of participants used therapeutic footwear and 46% were adherent with wearing it. The DFU recurrence rate among patients who used therapeutic footwear was 27.8% versus 52.5% among patients who did not (p = 0.013). While using therapeutic footwear, patients with foot deformities reported a lower ulcer healing rate than those who did not (50% vs. 81.8%, p = 0.04). Patients who examined their feet had a lower recurrence rate than those who did not (38.5% vs. 50%, p = 0.43).

Conclusion: Therapeutic footwear use was significantly associated with decreased DFU recurrence. Further investigation to enhance the evidence for the effectiveness of therapeutic footwear in DFUs is warranted.
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Perspectives toward feet, foot health, and footwear

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Activity and footwear characteristics in people with and without plantar heel pain

Young children’s footwear taxonomy

FTC suing Gravity Defyer footwear

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