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.
| Original language | English (US) |
|---|---|
| Article number | e70029 |
| Journal | International Wound Journal |
| Volume | 21 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 2024 |
Funding
This study was funded by a grant from ProgenaCare Global to the Professional Education and Research Institute, Roanoke VA. Globally, there are 18.6 million people who develop a diabetic foot ulcer (DFU) every year, including 1.6 million people in the United States.1,2 The lifetime incidence for Type II diabetics developing a DFU is 34%,3 which places a significant strain on patients, caregivers, healthcare providers and health systems throughout the world. In fact, DFUs account for more than 80% of all lower extremity amputations,4 and in the United States constitute nearly one-third of the annual direct costs for diabetes.5 Remarkably, the 5-year mortality rate for people who experience a DFU is 30% and exceeds 70% for individuals who suffer a major (above the ankle) amputation.6 Furthermore, approximately 70% of DFUs heal with a good standard of care (SOC), but at least 30% progress to chronic wounds.7 According to recent data, between 2014 and 2019 the number of Medicare beneficiaries with a wound increased from 8.2 to 10.5 million.8 Although the overall cost for chronic wound care modestly decreased during that time, from $29.7 to $22.5 billion,8 there remains a significant need to develop effective wound care treatments that improve outcomes, decrease costs and increase ulcer-free and activity-rich days. One such modality for healing chronic wounds is a human keratin matrix graft, ProgenaMatrix\u2122 (ProgenaCare Global, LLC, Marietta, GA, USA). ProgenaMatrix\u2122 is a novel, advanced wound care product constructed from human keratin and is the only human keratin matrix graft commercially available (Figure\u00A01). Keratin is a strong structural protein involved in cell\u2013cell and cell\u2013matrix interactions and provides strength and structure to keratinocytes. Keratinocytes, which are found in the epidermis, deposit keratin as a protective layer over the skin. Keratin has been shown to positively impact wound healing. A study published by Tang et al.9 showed that keratin stimulates human keratinocyte migration and types IV and VII collagen expression that contribute to wound healing. Keratin also plays a role in immunomodulation during the cell activation phase of wound healing,10 and findings from another study demonstrated that human keratin hydrogels support fibroblast attachment and proliferation in vitro.11 The human keratin technology in this unique human keratin matrix graft is hydrated, non-cellular, not tissue-based, resistant to protease degradation and supports the body's own healing process. The graft is manufactured from human keratin protein which is a sustainable raw material source. The matrix is made from all-natural components with no synthetic ingredients. It is a monolithic biomaterial made of protein and water. Keratin is the predominant protein with several keratin subtypes. The product also contains small amounts of other non-keratin proteins.12 This unique human keratin matrix graft is 510(k) approved for application on DFUs and other wound types and the satisfactory wound healing has been shown in numerous case studies presented at national wound care meetings. Based on this early promising data, the larger study presented here is necessary to further validate these results and identify the likelihood of wound healing with weekly versus bi-weekly application. If similar outcomes can be achieved with bi-weekly application, substantial savings to the health care system is possible. Due to the durable nature of the human keratin matrix graft even in the presence of proteases and a complex DFU, the authors hypothesised that bi-weekly application may be as effective as weekly application.
Keywords
- diabetic foot ulcer
- human keratin matrix graft
- wound healing
ASJC Scopus subject areas
- Surgery
- Dermatology
