Treatment of diabetic foot ulcers with dehydrated amniotic membrane allograft

NewsBot · Jul 14, 2016

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Treatment of diabetic foot ulcers with dehydrated amniotic membrane allograft: a prospective case series.
Abdo RJ
J Wound Care. 2016 Jul;25(Sup7):S4-S9.

OBJECTIVE:
A diabetic foot ulcer (DFU) is one of the many potential complications associated with diabetes. If not effectively and rapidly treated, DFUs can result in lower extremity amputations. This prospective case series aimed to assess the effectiveness of a dehydrated amniotic-derived tissue allograft (DAMA), with regards to time to wound closure and total number of applications.
METHOD:
Patients were recruited with a neuropathic non-healing DFU(s) despite standard care for at least 4 weeks before the study. The number of DAMA applications and time between applications was based on the physician's judgment. For the majority of patients (n=13/14), offloading, usually total contact casting (TCC), was used in conjunction with DAMA. Wounds were assessed, measured, and photographed every 1-2 weeks.
RESULTS:
Cases included 14 patients (11 men, 3 women; mean age 56.7?9.1 years) with 15 non-healing neuropathic DFUs with a mean baseline wound area of 6.5?11.6cm2 (median: 2.2cm2; range: 0.1-44.2cm2) and mean volume of 4.3?10.9cm3 (median: 0.3cm3; range: 0-39.8cm3). All patients in this series achieved complete wound closure within a median time of 5 weeks (range: 1-14 weeks). Wound area was reduced by a median of 58.3% at week 1 and 74.1% at week 3, and volume by a median of 62.8% at week 1, 97.4% at week 3 and by a median of 100% at week 5 and all time points thereafter. Patients received a median of 2 DAMA applications (range: 1-11). In those that required more than 1 application (n=12), DAMA was applied at intervals of 1 week (n=3) or ≥2 weeks (n=9). Smaller wounds (areas <2.2cm2) closed rapidly (<1 month, 1-2 applications), whereas larger wounds (>2.2cm2) required >2 weekly/biweekly applications.
CONCLUSION:
The use of DAMA, particularly when coupled with TCC, led to wound closure of DFUs in all patients in this case series, including complex patients with DFUs of ≥1 year in duration, lack of prior response to conservative treatment measures, area >10cm2 and/or multiple comorbidities. Prospective randomised trials would help to elucidate the precise role of DAMA in these encouraging results.
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NewsBot · Jul 20, 2016

A Retrospective Case Series of a Dehydrated Amniotic Membrane Allograft for Treatment of Unresolved Diabetic Foot Ulcers
Barry I. Rosenblum
JAPMA; online first

Background: Foot ulcers are among the most serious complications of diabetes and can lead to amputation. Diabetic foot ulcers (DFUs) often fail to heal with standard wound care, thereby making new treatments necessary. This case series describes the addition of a dehydrated amniotic membrane allograft (DAMA) to standard care in unresolved DFUs.

Methods: This is a single-center retrospective chart review of eight patients who had one to three applications of DAMA to nine DFUs that had failed to resolve despite offloading, other standard care, and adjuvant therapies. Following initial DAMA placement, wound size (length, width, depth) was measured every 1 to 2 weeks until closure. The principal outcome assessed was mean time to wound closure; other outcomes included mean percent reduction from baseline in wound area and volume at weeks 2 to 8.

Results: All wounds were closed a mean of 9.2 weeks after the first DAMA application (range, 3.0-13.5 weeks). Compared with baseline, wound area and volume, respectively, were reduced by a mean of 48% and 60% at week 2 and by 89% and 91% at week 8. Time to closure was shorter among four patients who had three DAMA applications (mean, 8.3 weeks; range, 4.0-11.0 weeks) than among three patients who had only one application (mean, 12.1 weeks; range, 9.5-13.5 weeks).

Conclusions: Chronic, unresolved DFUs treated with DAMA rapidly improved and reached closure in an average of 9.2 weeks. These cases suggest that DAMA can facilitate healing of DFUs that have failed to respond to standard treatments.
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NewsBot · Feb 1, 2017

Use of a Dehydrated Amniotic Membrane Allograft in the Treatment of Lower Extremity Wounds: A Retrospective Cohort Study.
Lullove EJ
Wounds. 2017 Jan 23. pii: WNDS2017123-2.

Injuries to the skin are extensively costly to the health care system. When caused by metabolic and vascular compromise, these injuries are even more foreboding for patients. They can result in chronic inflammation, reduced mobility, and chronic pain.
MATERIALS AND METHODS:
Twenty patients were selected from the author's patient population at the West Boca Center for Wound Healing for a retrospective cohort study. Patients underwent a run-in period of 2 weeks, where standard of care was used to clear the wound of bioburden. A dehydrated, human amniotic membrane (dHAM; WoundEx Membrane, Skye Biologics, Inc, El Segundo, CA) was applied at weeks 1 (2 weeks post run-in), 3, and 5, if necessary. Wound measurements and photographs were performed weekly. Data were collected through a standard form in each patient's medical record to improve reliability and reproducibility. The data extraction was performed by the author and to reduce bias. Reduction of bias was performed by selecting patients whose wounds already were established and in temporal sequence.
RESULTS:
In this review of 20 patients treated with the dHAM, the author was able to effectively close all wounds in approximately 9.9 weeks (69.3 days). A linear relationship was discovered between wound size in cm2 and days to closure. Diabetic foot ulcers closed on average in 11.8 weeks (82.6 days) and venous leg ulcers in 9.2 weeks (64.4 days). No adverse events were noted secondary to the dHAM application, which shows this is a safe and effective treatment option. As of the date of this publication, there is no recurrence of the ulcerations noted.
CONCLUSION:
The use of this particular dHAM allograft effectively closed diabetic foot ulcerations in 82.6 days and median wound closure in 69.3 days. This poses as an advantageous clinical benefit in the scope of treatment of lower extremity wounds.
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NewsBot · May 17, 2017

Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis.
Haugh AM et al
Plast Reconstr Surg Glob Open. 2017 Apr 25;5(4):e1302

BACKGROUND:
Amniotic membrane is tissue obtained from human placenta rich in cytokines, growth factors, and stem cells that possess the ability to inhibit infection, improve healing, and stimulate regeneration.
METHODS:
A meta-analysis was performed examining randomized controlled trials comparing amniotic tissue products with standard of care in nonhealing diabetic foot ulcers including PubMed, Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews.
RESULTS:
A search of 3 databases identified 596 potentially relevant articles. Application of selection criteria led to the selection of 5 randomized controlled trials. The 5 selected randomized controlled trials represented a total of 311 patients. The pooled relative risk of healing with amniotic products compared with control was 2.7496 (2.05725-3.66524, P < 0.001).
CONCLUSIONS:
The current meta-analysis indicates that the treatment of diabetic foot ulcers with amniotic membrane improves healing rates in diabetic foot ulcers. Further studies are needed to determine whether these products also decrease the incidence of subsequent complications, such as amputation or death, in diabetic patients.
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NewsBot · Sep 13, 2017

Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-analysis.
Laurent I et al
Diabetes Ther. 2017 Sep 11. doi: 10.1007/s13300-017-0298-8

INTRODUCTION:
Diabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients. The objective of this study was to assess the efficacy and time sensitivity of human amnion/chorion membrane treatment in patients with chronic DFUs.
METHODS:
The Cochrane Library, PubMed, Embase and Web of Science databases were systematically searched to identify relevant articles up to 10 April 2017. All randomized controlled trials (RCTs) comparing human amnion/chorion membrane + standard therapy and standard therapy alone in patients with DFUs were included in the analysis. Eligible studies were reviewed and data extracted into standard form. The Cochrane Collaboration's tool for assessing the risk of bias was used. Review manager version 5.3 software was used for statistical analysis. Data were analyzed using a random effect model.
RESULTS:
Overall, the initial search of the four databases identified 352 published studies; of these, seven RCTS were ultimately included in the meta-analysis. The overall test effect in the group assessed at 4 weeks was Z = 4.14 [P < 0.0001; odds ratio (OR) 0.05; 95% confidence interval (CI) 0.01-0.21]. The overall test effect in the group assessed at 6 weeks was Z = 4.28 (P < 0.0001; OR 0.07; 95% CI 0.02-0.23). The overall effect in the group assessed at 12 weeks was Z = 4.96 (P < 0.00001; OR 0.10; 95% CI 0.04-0.24. The results showed that patients receiving amniotic membrane + standard therapy had far fewer incomplete healing wounds than those receiving standard of care alone. Assessment of the wound healing state at 4 and 6 weeks revealed that the wound healing state was almost the same, but there was a net difference of wound healing state at 12 weeks.
CONCLUSION:
Human amnion/chorion membrane + standard of care treatment heals DFUs significantly faster than standard of care alone. When using the amnion in patients with DFUs, the optimal times to assess progress in wound healing should be 4 and 12 weeks.
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NewsBot · Feb 9, 2018

Biological effects of amniotic membrane on diabetic foot wounds: a systematic review.
Paggiaro AO et al
J Wound Care. 2018 Feb 1;27(Sup2):S19-S25. doi: 10.12968/jowc.2018.27.Sup2.S19.

OBJECTIVE:
The amniotic membrane has biological properties that are beneficial to the wound healing process of diabetic foot ulcers (DFU). Our aim is to analyse the scientific evidence found in literature on the use of the amniotic membrane to stimulate DFU healing.

METHOD:
A systematic review of amniotic membrane's influence was undertaken, using the search terms 'placenta' 'diabetic foot' 'amnion' and biological dressing', assessing the outcomes 'wound healing' and 'wound healing time', in DFU. Following the inclusion and exclusion criteria, randomised controlled trials (RCT) were identified, and the risk of bias was analysed according to the Cochrane risk of bias tool. We conducted a meta-analysis of the two outcomes to evaluate the level of evidence.

RESULTS:
We identified six clinical trials, with a total of 331 patients. The most common risks of bias in the studies were selection, attrition, and detection biases. From the meta-analysis, although the result difference of the intervention group (amnion) in relation to the control group was not statistically significant, we found that wound healing in the group treated with amniotic membrane occurs 2.32 times more often and is 32 days faster in comparison with the group that used conventional dressings.

CONCLUSION:
There is no statistical evidence to support the effectiveness of amniotic membrane in comparison with other conventional dressings. However, there is a clear tendency for the use of amniotic membrane treatment to result in a larger number of DFUs healing at a quicker rate.
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NewsBot · May 19, 2019

Comparing Human Amniotic Allograft and Standard Wound Care When Using Total Contact Casting in the Treatment of Patients with Diabetic Foot Ulcers
Thompson, Patricia, MS, RN; Hanson, Darlene S., PhD, RN; Langemo, Diane, PhD, RN, FAAN; Anderson, Julie, PhD, RN
Advances in Skin & Wound Care: May 8, 2019 - Volume Publish Ahead of Print - Issue - p

OBJECTIVE: This prospective, randomized study compared two treatments for diabetic foot ulcers: total contact cast and a skin substitute versus total contact cast and standard wound care.

PARTICIPANTS: Researchers screened 270 adult outpatients in a Midwestern wound care clinic for inclusion. Adults 18 years or older with type 1 or 2 diabetes and a diabetic foot ulcer located on the plantar surface larger than 0.5 cm2 in area were invited to participate if they had not demonstrated a 50% reduction in wound area following 4 weeks of standard treatment. Thirteen patients were randomized into two intervention groups. The majority of the participants had type 2 diabetes.

INTERVENTIONS: Group A treatment: total contact cast and a skin substitute (human amniotic allograft); group B treatment: total contact cast and standard wound care.

OUTCOME MEASURES: Mean ulcer surface area, time to closure, recurrence rates, satisfaction with total contact casting, infection, and hemoglobin A1c were measured.

RESULTS: The majority of participants experienced wound closure during the course of the study (92.3%). Two participants did not achieve closure, both of whom had Charcot foot. Group A, which had a higher mean hemoglobin A1c at study outset, experienced a longer mean time to closure (29.50 days) compared with group B (26.20 days). The 90-day recurrence rates were different for the two groups, with only one recurrence for group A (14.29%) but five recurring ulcers in group B (83.33%).

CONCLUSIONS: Although significance was not established because of sample size, there was a definite trend toward significance that merits further investigation with human amniotic allograft.
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NewsBot · Nov 8, 2019

A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers.
Serena TE et al
J Comp Eff Res. 2019 Nov 6

Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16-2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.
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NewsBot · Mar 5, 2020

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta‐analysis of randomised controlled trials
Ya‐Na Su Ding‐Yun Zhao Yong‐Hong Li Tian‐Qi Yu Huan Sun Xin‐Yu Wu Xiao‐Qin Zhou Jing Li
IWJ: 02 March 2020

To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta‐analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: −30.33 days, [95% CI: −37.95, −22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.
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NewsBot · May 30, 2020

Biological Characterization of Dehydrated Amniotic Membrane Allograft: Mechanisms of Action and Implications for Wound Care
Marc C Moore et al
J Biomed Mater Res B Appl Biomater. 2020 May 26

There is a growing clinical demand in the wound care market to treat chronic wounds such as diabetic foot ulcers. Advanced cell and tissue-based products (CTPs) are often used to address challenging chronic wounds where healing has stalled. These products contain active biologics such as growth factors and cytokines as well as structural components that support and stimulate cell growth and assist in tissue regeneration. This study addresses the in vitro biologic effects of a clinically available dehydrated amniotic membrane allograft (DAMA). The broad mechanism of action results from DAMA's biologic composition that leads to stimulation of cell migration cell proliferation, and reduction of pro-inflammatory cytokines. Results show that DAMA possesses growth factors and cytokines such as EGF, FGF, PDGFs, VEGF, TGF-β, IL-8, and TIMPs 1 and 2. Furthermore, in vitro experiments demonstrate that DAMA stimulates cell proliferation, cell migration, secretion of collagen type I, and the reduction of pro-inflammatory cytokines IL-1β, IL-6, and TNF-α. This study findings are consistent with the clinical benefits previously published for DAMA and other CTPs in chronic wounds suggesting that the introduction of DAMA to non-healing, complex wounds helps to improve the wound milieu by providing essential structural components, cytokines, and growth factors to create an appropriate environment for wound healing.
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NewsBot · Jun 24, 2020

Early Advanced Therapy for Diabetic Foot Ulcers in High Amputation Risk Veterans: A Cohort Study
Margaret Doucette et al
Int J Low Extrem Wounds. 2020 Jun 22

Veterans with diabetic foot ulcers (DFUs) represent the highest percentage of lower extremity amputations (LEAs) within the Veterans Affairs (VA) population. Many veterans have additional risk factors for amputation. Few studies focus on advanced therapies for this population. This study explores the impact of early application of dehydrated human amniotic membrane allograft (DAMA) with comprehensive care on preventing amputation. This prospective, single-center cohort study (ClinicalTrials.gov Identifier NCT02632929) was conducted through Boise VA Medical Center. Patients with DFUs were objectively stratified for LEA risk. Those with moderate to high amputation risk could participate. Participants received comprehensive care and weekly application of DAMA. Primary endpoint was avoidance of major LEA. Secondary endpoint was wound epithelialization. Monitoring continued 4 months. Between July 2015 and March 2017, 20 patients (mean age 67.2 years) with 24 DFU classified as moderate (12 wounds) to high risk (12 wounds) for amputation were enrolled. Wound volumes ranged from 0.072 cm3 to 56.4 cm3. Risk factors included neuropathy (20 patients), osteomyelitis (16 wounds), exposed tendon/ligament/bone (19 wounds), Charcot (5 patients), and peripheral arterial disease (13 wounds). All subjects avoided amputation within the study period, all 24 wounds achieved re-epithelialization within 4 to 33 weeks; mean healing time 13.2 weeks. Cost for the DAMA tissue ranged from $750 to $38 150. Estimated cost for LEA ranges from $30 000 to $50 000. No treatment-related adverse events during the study period were reported. The results suggest that early and frequent application of DAMA with comprehensive care may help prevent amputation. Additional research will help inform third-party payors and clinicians.
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NewsBot · Aug 19, 2021

Diabetic Foot Wounds Treated With Human Amniotic Membrane and Low-level Laser Therapy: A Pilot Clinical Study
Joelita de Alencar F Santos et al
Wound Manag Prev. 2021 Aug;67(8):16-23.

Background: Low-level laser therapy (LLLT) and human amniotic membrane (HAM) application have been shown to be viable options for use in wound healing.

Purpose: This study sought to compare LLLT and HAM to a control treatment (hydrogel, saline, and gauze) in persons with diabetes mellitus (DM) and foot ulcers.

Methods: Using a prospective pilot clinical study design, patients receiving care at a health center that specializes in the treatment of diabetic foot wounds between November 2016 and August 2017 were recruited. Eligible patients had to be 30 to 59 years of age; diagnosed with type 2 DM (postprandial capillary glucose levels between 140 and 350 mg/dL); and have uninfected, granulating stage 2 or 3 foot ulcers measuring less than 7 cm by 3 cm. Immunosuppressed and malnourished patients or those with neoplasms or in critical condition were not eligible to participate. Patients received the control treatment (2 mg hydrogel, saline, and gauze), HAM (patches of thawed HAM, applied with overlapping edges), or LLLT (phototherapy session, 2 mg hydrogel, saline, and gauze) for 28 days. Variables, wound area measurements, Pressure Ulcer Scale for Healing (PUSH) scores, and Visual Analog Scale (VAS) scores were used to assess wound improvement progress and pain on days 7, 14, 21, and 28. Descriptive statistics were used to analyze the participant anthropometric and clinical profiles. The Kolmogorov-Smirnov test was used to analyze the sample distribution. The Kruskal-Wallis test with Dunn's post-test was used to evaluate differences in PUSH and VAS scores and wound size for intergroup analysis, and the Mann-Whitney U test was used for the same outcomes in intragroup analysis. The level of significance was 5% (P < .05).

Results: Twenty-seven (27) patients participated (mean age, 51.4 years; mean body mass index, 26.5 kg/m2), with 9 patients in each treatment group. No statistically significant differences were noted in clinical or anthropometric variables among the groups, but mean baseline wound areas were different (2.6 cm² for the control, 1.9 cm² for the LLLT, and 5.5 cm² for the HAM groups). Intragroup comparisons showed a significant reduction in PUSH score in the LLT group between days 0 and 21 (8.2 vs 4.9; P < .01) and days 21 to 28 (4.9 vs 3.2; P < .001). In all treatment groups the percent reduction was significantly different between days 7 and 28. No outcomes were significantly different between groups.

Conclusion: Diabetic foot ulcer wound area as well as PUSH and VAS scores showed more improvement for patients with DM receiving LLLT or HAM than for the control group, but the differences were not significant. Larger studies are needed to compare these treatment modalities.
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NewsBot · Mar 9, 2024

Use of hypothermically stored amniotic membrane on diabetic foot ulcers: a multicentre retrospective case series
Anna Sanchez et al
J Wound Care. 2024 Mar 1;33(Sup3):S16-S23

Objective: The aim of this retrospective case series was to report on the outcomes of diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM).

Method: Deidentified case data of patients who received HSAM were obtained from wound care sites across the US. Data were collected, beginning at the first patient visit to the wound care site (first presentation), at the visit in which the first HSAM application occurred (baseline), and at each subsequent visit over 12 weeks of treatment (follow-up). All patients received standard of care (SoC) between first presentation and baseline.

Results: Of the 50 patients in the study, 68% were male. Mean age of the entire cohort was 66.7 years. Of the DFUs, 88% were present for <6 months at first presentation. Mean wound area was 3.5cm2, and mean percentage area reduction was -68.3% from first presentation to baseline. The mean number of HSAM applications was 5.5, and mean number of days between applications was 7.5. A >60% area reduction was attained in 96.0% of DFUs, and 78% attained complete wound closure (CWC) by week 12. The median time to CWC was 55 days.

Conclusion: The results of this retrospective case series suggest positive outcomes for DFUs managed with HSAM. A reduction in time to CWC may lead to lesser financial burden and improved quality of life for DFU patients.
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