TY - JOUR
T1 - Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers
T2 - A prospective randomised controlled trial
AU - PriMatrix Study Group
AU - Lantis, John C.
AU - Snyder, Robert
AU - Reyzelman, Alexander M.
AU - Van Gils, Carl C.
AU - Sigal, Felix
AU - Vayser, Dean
AU - Caporusso, Joseph M.
AU - Cazzell, Shawn
AU - Lavery, Lawrence A.
N1 - Publisher Copyright:
© 2021 MA Healthcare Ltd. All rights reserved.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9%; p=0.008; mPP: 59.5% versus 35.6%; p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. Conclusions: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.
AB - Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9%; p=0.008; mPP: 59.5% versus 35.6%; p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. Conclusions: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.
KW - Acellular dermal matrix
KW - ADM
KW - Diabetes
KW - Diabetic foot ulcers
KW - Dressing
KW - Extracellular matrix
KW - Fetal bovine acellular dermal matrix
KW - Randomised controlled trial
KW - Skin substitute
KW - Wound
KW - Wounds
UR - http://www.scopus.com/inward/record.url?scp=85110292703&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85110292703&partnerID=8YFLogxK
U2 - 10.12968/jowc.2021.30.Sup7.S18
DO - 10.12968/jowc.2021.30.Sup7.S18
M3 - Article
C2 - 34256588
AN - SCOPUS:85110292703
SN - 0969-0700
VL - 30
SP - S18-S27
JO - Journal of wound care
JF - Journal of wound care
ER -