Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis.
Open accessAbstract
BACKGROUND: Diabetic foot ulcer (DFU) is one of the most serious diabetic complications. DFU is an open wound that usually occurs in the foot sole due to poor blood glucose control, peripheral neuropathy, and poor circulation. The human amniotic allograft membrane is a biological wound dressing derived from the amniotic membrane. It contains amino acids, nutrients, cytokines, and growth factors that make the growth process easier. OBJECTIVE: To compare dehydrated human amnion and chorion allograft (DHACA) plus the standard of wound care (SOC) with the SOC alone. METHODS: We searched for randomized clinical trials (RCTs) on PubMed, Scopus, Cochrane, and Web of Science till April 2021 using relevant keywords. All search results were screened for eligibility. We extracted the data from the included trials and pooled them as mean difference (MD) or risk ratio (RR) with the 95% confidence interval (CI) using Review Manager software (ver. 5.4). RESULTS: The pooled effect estimate from 11 RCTs showed that DHACA was superior to SOC regarding the complete wound healing in both 6th and 12th week (RR = 3.78; 95% CI: [2.51, 5.70]; P < 0.00001) and (RR = 2.00; 95% CI: [1.67, 2.39], P < 0.00001 respectively). Also, the analysis favored the DHACA regarding the mean time to heal in the 12th-week (MD = -12.07, 95%CI: [-19.23, -4.91], P = 0.001). The wound size reduction was better with DHACA (MD = 1.18, 95%CI: [-0,10, 2.26], P = 0.03). CONCLUSION: Using DHACA with SOC is safer and more effective than using SOC alone for DFU patients.
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In one randomized clinical trial of 64 participants, Achilles tendon lengthening significantly reduced forefoot plantar pressure compared with presurgical levels (647.2 [SD, 306.7] kPa vs 892.4 [SD, 176.6] kPa; P = .005).
“One randomized clinical trial of 64 participants showed significantly reduced forefoot plantar pressure compared with presurgical levels (647.2 [SD, 306.7] kPa vs 892.4 [SD, 176.6] kPa; P = .005),”
From Diabetic Foot Ulcers (2023) · cites this paper as [61]
The Results > Outcomes and Discussion passages report healing outcomes for amniotic membrane products, not Achilles tendon lengthening or plantar pressure. Searches for Achilles tendon lengthening and the quoted pressure values found no passage addressing the claimed 64-participant trial. Page numbers were not available in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn that trial, Achilles tendon lengthening combined with a total contact cast had a small, nonsignificant effect on healing of foot ulcers compared with a total contact cast alone (relative risk, 1.10; 95% CI, 0.96-1.27).
“a small, nonsignificant effect on healing of foot ulcers when combined with a total contact cast compared with a total contact cast alone (relative risk, 1.10; 95% CI, 0.96-1.27),”
From Diabetic Foot Ulcers (2023) · cites this paper as [61]
The Results (Outcomes; page unavailable) report healing effects for amniotic membrane products plus standard care, not Achilles tendon lengthening plus a total contact cast. A search of our copy for Achilles tendon lengthening and the stated RR and confidence interval found no passage reporting that trial result; the Studies characteristics table mentions a total contact cast only in a different comparison. (LLM, conf=0.78)
Experimental — accuracy not yet measuredIn that trial, Achilles tendon lengthening reduced risk of recurrence for patients in diabetic foot ulcer remission (relative risk, 3.4; 95% CI, 1.4-8.2).
“and reduced risk of recurrence for patients in diabetic foot ulcer remission (relative risk, 3.4; 95% CI, 1.4-8.2). 51,61”
From Diabetic Foot Ulcers (2023) · cites this paper as [61]
The Discussion and Results > Outcomes sections evaluate amniotic membrane products for healing active diabetic foot ulcers, not Achilles tendon lengthening in patients whose ulcers are in remission. Searches for Achilles tendon lengthening, recurrence, and the stated risk ratio and confidence interval found no passage addressing the claim; page numbers were not available in our copy. (LLM, conf=0.77)
Experimental — accuracy not yet measured
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- Authors
- Mohammed, Y. A., Farouk, H. K., Gbreel, M. I., Ali, A. M., Salah, A. A., Nourelden, A. Z., & Gawad, M. M. A.
- Affiliations
- Assiut University (EG)
- Fayoum University (EG)
- October 6 University (EG)
- Faculty of Medicine Minia University Minia Egypt
- Al-Azhar University (EG)
- Faculty of Medicine Al‐Fayoum University Fayoum Egypt
- Corresponding author
- Mohammed, Yasmine Adel
- Venue
- Journal of Foot and Ankle Research
- Publisher
- Wiley
- Published
- 2022-01
- Volume
- 15
- Issue
- 1
- Pages
- 71-71
- ISSN
- 1757-1146 (ISSN-L)
- PMC
- PMC9472416
- OpenAlex
- W4295898654
- Cited by
- 36
- References
- 35
- Citations by year
- 2026: 4 · 2025: 11 · 2024: 15 · 2023: 6
- FWCI
- 1.14
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Foot and Ankle Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Assiut University
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
- Keywords
- diabetic foot ulcer, wound healing, wound dressings, healing time, wound size reduction, diabetes complications
- MeSH terms
- Amnion, Diabetes Mellitus, Humans, Wound Healing, Treatment Outcome, Diabetic Foot, Standard of Care
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