Clinical effectiveness of different off-loading devices for the treatment of neuropathic foot ulcers

NewsBot · Oct 1, 2024

Offloading systems for the treatment of neuropathic foot ulcers in patients with diabetes mellitus: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome
Carlotta Gauna, Francesco Romeo, Alessia Scatena, Cesare Miranda, Luigi Uccioli, Cristiana Vermigli, Antonio Volpe, Corrado Bordieri, Rodolfo Tramonta, Benedetta Ragghianti, Giulia Bandini, Matteo Monami & Luca Monge for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome* and on behalf of SID and AMD
15 March 2024

To compare the effectiveness of commonly used offloading devices for the treatment of neuropathic foot ulcers in patients with diabetes mellitus. This meta-analysis (MA) has been performed for giving an answer to clinical questions on this topic of the Italian guideline on diabetic foot syndrome.

Methods
The present MA includes randomized controlled studies (duration > 12 weeks) comparing, in patients with diabetes mellitus and non-infected neuropathic foot ulcer: any offloading device vs either no offloading device or conventional footwear; removable versus non-removable offloading devices; surgical procedure vs other offloading approaches. The primary endpoint was ulcer healing.

Results
A total of 184 studies were identified, and 18 were considered eligible for the analysis. We found that: any plantar off-loading, when compared to the absence of plantar offloading device, is associated with a higher ulcer healing (MH-OR: 3.13 [1.08, 9.11], p = 0.04, I2 = 0%); total contact cast or nonremovable knee-high walker, compared to other offloading devices, had a higher ulcer healing rate (MH-OR: 2.64 [1.43, 4.89], p = 0.002, I2 = 51%); surgical offloading for active ulcers in combination with post-surgery offloading achieves higher ulcer healing rate when compared to offloading devices alone (MH-OR: 6.77 [1.64, 27.93], p = 0.008, I2 = 0%).

Conclusions
Any plantar offloading, compared to the absence of plantar offloading device, is associated with a higher ulcer healing rate. Total contact cast or nonremovable knee-high walker, compared to other offloading devices, is preferable. Surgical offloading for active ulcers, in combination with post-surgery offloading devices, achieves a higher ulcer healing rate when compared to other offloading devices alone. Further studies with a larger cohort of patients with diabetic neuropathic foot ulcers and extended follow-up periods are necessary.
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NewsBot · Dec 4, 2024

Comparative Analysis of Three Types of Therapeutic Offloading Diabetic Shoes With Custom Made Insole on Plantar Pressure Distribution in Severe Diabetic Charcot Foot
M Nouman et al
Can Prosthet Orthot J. 2024 Aug 17;7(1):41780

Background: Charcot foot deformity, a severe complication of diabetes, involves neuropathy and abnormal peak plantar pressure in the midfoot and forefoot. However, orthotic interventions and shoe modifications are used to address the sequelae of Charcot neuroarthropathy, offering different approaches to managing abnormal peak plantar pressure.

Objective: To compare the effects of three types of therapeutic offloading diabetic shoes; prefabricated, relasting, and double rocker-modified shoes on peak plantar pressure in the midfoot and forefoot of nonulcerated chronic Charcot foot during walking.

Methodology: A repeated measure design involved 15 participants (40% males and 60% females) with a mean age of 60.73 years (SD=10.50), with Charcot neuropathy. Participants were provided with three types of shoes; prefabricated, relasting, and double rocker-modified shoes, each equipped with the same custom-made insole (CMI). Plantar pressure was recorded while walking on level ground, focusing on the forefoot, midfoot, and hindfoot. The study also investigated additional variables affecting plantar pressure distribution, including the pressure-time integral and contact area.

Findings: The type of shoe had distinct effects on the distribution of plantar pressure. The double rocker-modified shoe particularly impacted forefoot pressure during the terminal stance phase of the gait cycle. Peak plantar pressure at the forefoot increased by 5.37% with double rocker-modified shoes compared to relasting shoes. Both double rocker-modified and prefabricated shoes reduced midfoot peak plantar pressure by 8.73% and 11.97%, respectively. Similar trends were observed at the hindfoot, with reductions in peak plantar pressure. However, there were no significant differences in regional peak plantar pressure between the types of shoes except for the central forefoot (F (1.61, 22.5) = 5.69, p = 0.014).

Conclusion: There were no significant differences in the effectiveness of prefabricated, relasting, and double rocker-modified shoes in reducing and redistributing peak plantar pressure in high-risk areas of chronic Charcot foot.
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NewsBot · Jan 10, 2025

Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
Hany M Elgohary et al
Medicina (Kaunas). 2024 Dec 16;60(12):2066.

Background and Objectives: Patients with diabetes polyneuropathy are at a heightened risk for developing foot ulcers, often due to dynamic plantar foot pressure patterns that lead to increased pressure and shear forces in specific foot areas. This study aimed to evaluate the effects of foot insoles on peak pressure and the pressure-time integral in patients with polyneuropathy diabetic foot ulcers over a twelve-week period followed by an eight-week follow up. Materials and Methods: This was a prospective, randomized, double-blinded, controlled clinical trial involving 60 patients aged between 50 and 65 years of both genders. Inclusion criteria included midfoot ulcer grades II or III, a history of polyneuropathy diabetic foot ulcers lasting between six months and one year, diabetes duration of seven to ten years, glycated hemoglobin levels between 7% and 9%, and a body mass index (BMI) ranging from 25 to 30 kg/m2. Participants were randomly assigned to either the study group, which received foot insoles along with medication and wound care, or the control group, which received only medication and wound care. Measurements of peak pressure and pressure-time integrals were taken at the start of this study, after twelve weeks, and again eight weeks post-study. Results: The results indicated significant differences in peak pressure and pressure-time integral measurements for the rearfoot, midfoot, hallux, and both medial and lateral forefoot areas after twelve weeks of using foot insoles compared to the control group. This suggests that the use of foot insoles effectively reduces peak pressure and the pressure-time integral in these critical areas. Conclusions: The findings of this study support the use of foot insoles as a beneficial intervention for decreasing peak pressure and the pressure-time integral on the hallux, medial, and lateral forefoot in patients with polyneuropathic diabetic foot ulcers, and they could play a crucial role in preventing further complications.
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NewsBot · May 29, 2025

The Use of Multilayer Felt Padding in the Treatment of Neuropathic Plantar Foot Ulcerations
Khanh Phuong Tong et al
J Am Podiatr Med Assoc. 2025 Jan-Feb;115(1):22-088. doi: 10.7547/22-088.

Background: Neuropathic plantar foot ulcers are difficult to treat due to their location and the repetitive pressures applied during ambulation. Total-contact casts and removable off-loading devices are effective in off-loading pressures; however, patient intolerance and adherence are barriers to use. Felt padding can provide off-loading with greater tolerance. We present novel felt padding techniques that provide off-loading with greater adherence and may ultimately lead to greater rates of wound closure.

Methods: This retrospective study included patients with neuropathic plantar foot ulcers seen at a single center between August 1, 2016 and July 15, 2020. Felt padding was applied to the plantar foot during clinic visits. Ulcer characteristics, medical history, and treatment options were extracted and evaluated. Statistical analyses were performed with descriptive statistics, two-sample t tests, and Fisher exact tests. Kaplan-Meier method was used to estimate time to reach 50% ulcer surface area reduction.

Results: Of 59 included patients with neuropathy and a plantar foot ulcer treated with felt padding, 46 (78.0%) had diabetes mellitus. Mean ± SD surface area was 1.0 ± 1.8 cm2. Mean ± SD and median (interquartile range) healing times were 67.4 ± 76.3 days and 45 (40) days, respectively. The percentage healed by 12 weeks was 78.0%. There was no significant difference in healing times between diabetic and nondiabetic patients (P = .57).

Conclusions: Multilayer felt padding is an important adjunctive tool for off-loading and healing of neuropathic plantar foot ulcers. Use of multilayer felt off-loading padding should be considered for patients with suspected low adherence to wearing a removable knee-high or ankle-high off-loading device.
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NewsBot · Jun 5, 2025

Exploring air insole pressure and walking durations effects on microcirculation in healthy individuals to optimize diabetic foot ulcers prevention
Gilang Titah Ramadhan et al
Sci Rep. 2025 Mar 27;15(1):10603.

To evaluate the impact of air insole on reducing the risk of diabetic foot ulcers (DFUs) in healthy individuals through microcirculation assessment, which considers blood flow as a critical factor due to the role of peripheral vascular disease in DFU development. The study analyzes the interaction between air insole pressure and walking duration. Repeated-measures design was used to assess the effects of two walking durations (10 and 20 min) and three air insole pressures (80, 160, and 240 mmHg), resulting in six walking conditions tested in 13 healthy participants. The average blood flow in the first metatarsal head (M1) was quantified using data from the last 3 min of the 10 min post-exercise period. The results of one-way ANOVA showed that the 80 mmHg air insole pressure was significantly lower microcirculation than 240 mmHg with 10 min walking duration (129.4 ± 9.1 vs 163.1 ± 12.6 PU, P = 0.035). The paired t-test showed three significant differences in the effects of the walking duration in all air insole pressures. (1) 10 min walking duration was significantly lower compared to 20 min with 80 mmHg air insole pressure (129.4 ± 9.1 vs 203.6 ± 10.1 PU, P = 0.001); (2) 10 min walking duration was significantly lower compared to 20 min with 160 mmHg air insole pressure (142.5 ± 10.6 vs 206.0 ± 12.5 PU, P = 0.001); (3) 10 min walking duration was significantly lower compared to 20 min with 240 mmHg (163.1 ± 12.6 vs 219.1 ± 11.8 PU, P = 0.008). This study highlights that walking with an air insole pressure of 80 mmHg for 20 minutes influences microcirculation at the first metatarsal head, potentially offering important benefits for individuals at risk of pressure-related injuries, such as DFUs.
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NewsBot · Jun 8, 2025

Best practice offloading treatments for diabetic foot ulcer healing, remission, and better plans for the healing-remission transition
Peter A Lazzarini, Jaap J van Netten
Semin Vasc Surg. 2025 Mar;38(1):110-120.

Diabetes-related foot disease is arguably the world's least known major health problem and causes a disease burden larger than most well-known diseases, such as stroke and breast cancer. This burden is driven by people developing more severe stages of foot disease, such as foot ulcers and infections, and with that worsening quality of life. To reduce this burden, we need treatments that prevent more severe stages of foot disease and improve quality of life. Best practice offloading treatments have been found to be arguably the most effective existing treatments to heal and prevent diabetes-related foot ulcers and infections, but can worsen quality of life. Furthermore, high re-ulceration rates still occur with best practice offloading treatments after healing. This may be because of the gap in guideline recommendations on the transition from ulcer healing to ulcer remission when it comes to offloading treatments. In this paper, we review why we need offloading treatments and what are the best offloading treatments recommended by the latest international guidelines for healing and remission. Further, we propose plans for future best practice offloading treatments for the transition from healing-to-remission to help reduce re-ulceration rates and improve longer-term ulcer remission. These plans could be the catalyst for better transitioning patients from first ulcer presentation through healing and into long-term remission, and in turn delivering better quality of life, and lower diabetes-related foot disease burdens on patients, nations, and the globe in future.
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NewsBot · Jun 13, 2025

Offloading Strategies Used for Plantar Diabetic Foot Ulcers and Their Outcomes in Real-Life Clinical Practice
Afram Rumanes et al
J Clin Med. 2025 May 29;14(11):3834.

Introduction: International guidelines describe offloading to facilitate healing as a cornerstone in the treatment of diabetes-related foot ulcers. In present-day clinics, various offloading devices are used. The aim of this paper is to describe the effectiveness in healing of different offloading devices used in real-life clinical practice in patients with diabetes-related foot ulcers. Methods: A retrospective cohort study of 235 patients with a plantar foot ulcer in one diabetic foot centre of expertise was used. Clinical outcomes were determined during a follow-up period of 12 months. Groups were defined according to the types of offloading. Univariate and multivariate analysis was performed to assess ulcer-related outcomes in different offloading devices. Results: Of the 235 patients, 3% were treated with a Total Contact Cast (TCC), 9% with an ankle-high removable device, 32% with a custom-made orthopaedic shoe, 16% with a bandage shoe, and 39% with felted foam. Patients who received a bandage shoe or felted foam had a higher UT classification (Stage D in 21% and 18%, respectively, p = 0.001) and more ulcers per foot (13% and 5%, respectively, p = 0.002). The overall healing rate at 12 weeks was 33% and was not significantly different between the offloading device groups (p = 0.255). Healing rates at 20 and 52 weeks were 51.5% and 77%. Conclusions: Removable ankle-high offloading devices, orthopaedic shoes, bandage shoes, and felted foam are the most frequently used for plantar diabetic foot ulcers in clinical practice. This seems to be the result of various physician- and patient-related factors such as logistical reasons, patient factors, and severity of complicated ulcers. Diabetic foot ulcer healing after 12 weeks, 20 weeks, and 1-year follow-up were consistent with previous observational studies.
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NewsBot · Jun 27, 2025 at 12:56 AM

Removable and Nonremovable Off-Loading Devices
Sarah L Carter et al
J Am Podiatr Med Assoc. 2025 May-Jun;115(3):21-119.

Background: Diabetic foot ulcers are associated with a 12-fold increased risk of lower-extremity amputations and increased mortality rates. Off-loading is one of the many crucial interventions involved in healing diabetic foot ulcers. This study investigates various off-loading devices: total-contact cast (TCC), removable TCC (R-TCC) with and without brace, and removable controlled ankle motion walker, with further subdivision of plantar foot regions.

Methods: Previously collected deidentified data of 12 healthy participants from a study by Bhatt et al were used in the present study. Peak plantar pressure (PPP) of nine individual mask regions for each off-loading device were imported into a statistical software program for analysis.

Results: Removable controlled ankle motion walker, TCC, and R-TCC with brace had significant PPP reductions compared with controls in eight of the nine regions of the foot, except for the nonsignificant increase in PPP of the medial midfoot region. The R-TCC with brace had a nonsignificant PPP reduction difference compared with the TCC for six of the nine regions.

Conclusions: This study found new discoveries by further expanding on studies by Bhatt et al and subdividing the plantar foot into nine regions. The TCC remains the gold standard and first line of treatment for off-loading diabetic foot ulcers. These findings contradict those previously reported by Bhatt et al
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NewsBot · Jun 28, 2025 at 4:58 AM

A Portable Insole System for Actively Controlled Offloading of Plantar Pressure for Diabetic Foot Care
Pedro Castro-Martins et al
Sensors (Basel). 2025 Jun 19;25(12):3820.

Plantar pressure monitoring is decisive in injury prevention, especially in at-risk populations such as people with diabetic foot. In this context, innovative solutions such as pneumatic insoles can be essential in plantar pressure management. This study describes the development of a variable pressure system that promotes the monitoring, stabilization, and offloading of plantar pressure through a pneumatic insole. This research was also intended to evaluate its ability to redistribute plantar pressure, reduce peak pressure in both static and dynamic conditions, and validate its pressure measurements by comparing the results with those obtained from a pedar® insole. Tests were carried out under both static and dynamic conditions, before and after the pressure stabilization process by air cells and the subsequent pressure offloading. During the validation process, methods were used to evaluate the agreement between measurements obtained by the two systems. The results of the static test showed that pressure stabilization reduced pressure on the heel by 32.43%, distributing it to the metatarsals and toes. After heel pressure offloading, the reduction reached 42.72%. In the dynamic test, despite natural dispersion of the measurements, a trend to reduce the peak pressure in the heel, metatarsals, and toes was observed. Agreement analysis recorded 96.32% in the static test and 94.02% in the dynamic test. The pneumatic insole proved effective in redistributing and reducing plantar pressure, with more evident effects in the static test. Its agreement with the pedar® system reinforces its reliability as a tool for measuring and managing plantar pressure, representing a promising solution for preventing plantar lesions.
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NewsBot · Jun 29, 2025 at 1:02 AM

Comparison of the Effectiveness and Safety of Different Non-surgical Offloading Interventions for Diabetic Foot Ulcers: A Network Meta-analysis of Randomized Controlled Trials
Yuxia Wu et al
Int J Low Extrem Wounds. 2025 Apr 10:15347346251329609.

ObjectiveThe aim of this study is to conduct a network meta-analysis of the effectiveness and safety of different non-surgical offloading interventions for patients with diabetic foot ulcers.MethodsWe searched PubMed, EMBASE, OVID, Web of Science, and Cochrane Library for randomized controlled trials (RCTS) on the efficacy of non-surgical interventions for DFU offloading. Outcome measures included the rate of ulcer healing, reduction in ulcer area, and incidence of adverse events. The Cochrane Risk of Bias Tool version was used to assess the risk of bias of the included trials.ResultsA total of 22 RCTs involving 1226 patients were included. Network meta-analysis showed that compared to removable knee high offloading device (OR = 3.66, 95% CI (1.78, 8.46)], removable ankle high offloading device (OR = 3.17, 95% CI (1.32, 7.85)], therapeutic shoe (OR = 3.72, 95% CI (1.53, 9.78)], standard treatment (OR = 4.15, 95% CI (1.05, 13.89)], TCC significantly increased the ulcer healing rate (P < .05). The analyses did not reveal any statistically significant differences between the results of the various types of non-surgical offloading measures in terms of ulcer reduction area and incidence of adverse events. The ranking probability graph showed that TCC (SUCRA = 0.59) was most likely to improve ulcer healing rates, therapeutic shoes (SUCRA = 0.25) performed best in terms of ulcer reduction area, and non-removable walkers (SUCRA = 0.63) were most likely to reduce the incidence of adverse events.ConclusionsNon-removable offloading devices (TCC and non-removable walkers) have the best effectiveness and safety in the non-surgical offloading interventions of patients with diabetic foot ulcers, which is of great significance in promoting ulcer healing and improving prognosis.
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Clinical effectiveness of different off-loading devices for the treatment of neuropathic foot ulcers

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Clinical effectiveness of different off-loading devices for the treatment of neuropathic foot ulcers

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The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg,

Clinical Efficacy and Cost-Effectiveness of Bespoke and Prefabricated Foot Orthoses for Plantar Heel

Clinical effectiveness of customised sport shoe orthoses for overuse injuries in runners: a randomis

Clinical Methods for predicting the effectiveness of functional foot orthoses

Correlation between biomechanical experiments and clinical studies

Bridging the gap between custom foot orthoses research and clinical practice

New Clinical Test to Evaluate Intrinsic Foot Muscle Function

Share This Page

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