Journal article
A Prospective Multicenter Study of a Weekly Application Regimen of Viable Human Amnion Membrane Allograft in the Management of Nonhealing Diabetic Foot Ulcers
Plastic and reconstructive surgery. Global open, v 11(10), pp E5291-e5291
01 Oct 2023
PMID: 37811353
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background:Diabetic foot ulcers (DFUs) pose a significant clinical challenge for providers and patients, and often precede devastating complications such as infection, hospitalization, and amputation. Therefore, advanced treatment options are needed to facilitate the healing of chronic DFUs and improve outcomes in this high-risk population. Cryopreserved viable human amnion membrane allograft (vHAMA) has shown great promise in the treatment of recalcitrant DFUs as a supplement to standard of care (SOC). Placental grafts are rich in extracellular matrix proteins, growth factors, and cytokines, which can induce angiogenesis and dermal fibroblast proliferation, resulting in accelerated healing.Methods:In this prospective, multicenter single arm trial, 20 patients with nonhealing DFUs received weekly application of vHAMA, in addition to SOC, for up to 12 weeks. The primary study endpoint was proportion of healed wounds at 12 weeks. Secondary endpoints included proportion of wounds healed at 6 weeks, time to heal, and percentage area wound reduction. Subjects were evaluated for ulcer healing and assessed for adverse events at every treatment visit.Results:At study conclusion, 85% of patients receiving vHAMA healed. Ten wounds healed (50%) by 6 weeks, and 17 wounds (85%) healed by 12 weeks. The mean time to heal was 46.6 days (95% CI: 35.1-58.0), and the average number of vHAMAs used was 5.4 (SD: 3.25). The mean PAR was 86.3% (SD: 40.51).Conclusions:Aseptically processed, cryopreserved vHAMA should be considered as a safe and effective option for DFUs refractory to SOC therapy.
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Details
- Title
- A Prospective Multicenter Study of a Weekly Application Regimen of Viable Human Amnion Membrane Allograft in the Management of Nonhealing Diabetic Foot Ulcers
- Creators
- Robert D. Galiano - Northwestern UniversityDennis P. Orgill - Brigham and Women's HospitalDavid G. Armstrong - University of Southern CaliforniaPaul M. Glat - Drexel UniversityMarissa J. Carter - Global Strategic Solutions (United States)Charles M. Zelen - Professional Education and Research Institute
- Publication Details
- Plastic and reconstructive surgery. Global open, v 11(10), pp E5291-e5291
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 7
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:001080284800001
- Scopus ID
- 2-s2.0-85175185879
- Other Identifier
- 991021838265604721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Surgery