Lantis JC, Snyder R, Reyzelman AM, Van Gils CC, Sigal F, Vayser D, Caporusso JM, Cazzell S, Lavery LA, PriMatrix Study Group, et al.
Journal of wound care. Date of publication 2021 Jul 1;volume 30(Sup7):S18-S27.
1. J Wound Care. 2021 Jul 1;30(Sup7):S18-S27. doi:
10.12968/jowc.2021.30.Sup7.S18.
Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a
prospective randomised controlled trial.
Lantis JC(1), Snyder R(2), Reyzelman AM(3), Van Gils CC(4), Sigal F(5), Vayser
D(6), Caporusso JM(7), Cazzell S(8), Lavery LA(9); PriMatrix Study Group.
Author information:
(1)Mount Sinai West Hospital, Icahn School of Medicine, New York, NY, US.
(2)Barry University School of Podiatric Medicine, Miami, FL, US.
(3)Department of Medicine, California School of Podiatric Medicine and UCSF
Center for Limb Preservation, California School of Podiatric Medicine at Samuel
Merritt University, Oakland, CA, US.
(4)Foot & Ankle Institute, St. George, UT, US.
(5)Foot and Ankle Clinic, Los Angeles, CA, US.
(6)ILD Research Center, San Diego, CA, US.
(7)Futuro Clinical Trials, McAllen, TX, US.
(8)Limb Preservation Platform, Valley Vascular Surgical Associates, Fresno, CA,
US.
(9)University of Texas Southwestern, Dallas, TX, US.
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.
DOI: 10.12968/jowc.2021.30.Sup7.S18
PMID: 34256588 [Indexed for MEDLINE]
