Journal article
A multicentre clinical trial evaluating the outcomes of two application regimens of a unique keratin‐based graft in the treatment of Wagner grade one non‐healing diabetic foot ulcers
International wound journal, v 21(9), e70029
01 Sep 2024
PMID: 39245798
Abstract
Diabetic foot complications that lead to lower extremity amputations pose a significant challenge to the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic foot ulcers (DFUs) were treated with a unique human keratin matrix graft applied either weekly or bi‐weekly, in addition to standard of care. The hypothesis was that bi‐weekly application would be similar to weekly application. The primary endpoint was complete wound closure by 12 weeks, and secondary endpoints included healing time, percent area reduction and weekly changes in peripheral neuropathy, pain and quality of life. In the intent‐to‐treat population, 77% (10/13) of DFUs treated with bi‐weekly application healed compared with 69% (9/13) treated with weekly application. The mean time to heal within 12 weeks in the bi‐weekly group was 61 days and in the weekly group was 54 days. The mean percent area reduction at 12 weeks was 94.7% in the bi‐weekly group compared with 84.8% in the weekly group. The number of grafts used in the bi‐weekly group was 3.9 compared with 6.2 in the weekly group. The results of this trial confirm our hypothesis that whether bi‐weekly or weekly application of the unique keratin matrix graft is used to treat nonhealing indolent DFUs, there is a high rate of complete healing. Based on these results, future studies should be conducted that further investigate the use of this novel human keratin matrix graft for the treatment of chronic DFUs.
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2 citations in Scopus
Details
- Title
- A multicentre clinical trial evaluating the outcomes of two application regimens of a unique keratin‐based graft in the treatment of Wagner grade one non‐healing diabetic foot ulcers
- Creators
- David G. Armstrong - University of Southern CaliforniaDennis P. Orgill - Professional Education and Research InstituteRobert D. Galiano - Northwestern UniversityPaul M. Glat - Drexel UniversityMarissa J. Carter - Strategic Solutions ConsultingJason Hanft - Doctors HospitalMaria Surprenant - Doctors HospitalAdam L. Isaac - Foot and Ankle Specialists of the Mid‐Atlantic (FASMA)Charles M. Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 21(9), e70029
- Publisher
- Blackwell Publishing Ltd
- Grant note
- ProgenaCare Global
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Scopus ID
- 2-s2.0-85203390102
- Other Identifier
- 991021902492804721