A Multicenter, Randomized, Single-blind Trial Comparing the Efficacy of Viable Cryopreserved Placental Membrane to Human Fibroblast-derived Dermal Substitute for the Treatment of Chronic Diabetic Foot Ulcers

BACKGROUND: Randomized, controlled clinical trials (RCTs), the gold standard to determine treatment efficacy against a control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers (DFUs) in comparison with standard of care (SOC). However, RCTs comparing efficacy between skin substitutes are limited. With growing numbers of new skin substitutes, such studies are essential for treatment and policy-making decisions by wound-care providers and payers. 

OBJECTIVE: In this study, the authors analyzed clinical outcomes and product cost between a viable cryopreserved placental membrane (vCPM) and a human fibroblast-derived dermal substitute (hFDS) for the treatment of chronic DFUs in a prospective, multicenter, single-blind study (www.clinicaltrials.gov: NCT02675855). 

MATERIALS AND METHODS/RESULTS: The outcomes of 62 patients were analyzed: 31 patients in the vCPM group and 31 patients in the hFDS group. Utilizing a noninferiority trial design and the established treatment regimen of 8 applications for hFDS, they demonstrated vCPM was not inferior to hFDS for the proportion of patients achieving complete wound closure (9.68, 90% confidence interval: 10.67-28.94). However, for typical DFUs of > 5 cm², 81.3% (13/16) of wounds reached closure in the vCPM group vs. 37.5% (6/16) of wound closure in the hFDS group at the end of treatment (P = .0118). For wounds > 5 cm² average per-patient product costs during the course of treatment were $3846 and $7968 (P < .0001) for vCPM and hFDS, respectively. 

CONCLUSIONS: Herein, the authors demonstrated vCPM is noninferior to hFDS with regard to DFU closure when hFDS’s treatment regimen of 8 applications was used, but it may have better outcomes for wounds > 5 cm². A cost analysis for these wounds demonstrated a lower cost per patient for the vCPM product. Clinical and cost outcomes reported in this study may provide valuable guidance for wound care providers and payers.

CITATION
Ananian C, Dhillon YS, Van Gils CC, et al. A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to Human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers. Poster presented at: Symposium on Advanced Wound Care Fall; November 2-4, 2018; Las Vegas, NV.

Products: GrafixPRIME (Osiris Therapeutics, Inc, Columbia, MD); and Dermagraft (Organogenesis, Inc, Canton, MA)

This abstract was not subject to the WOUNDS peer-review process.

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