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

Purpose: Randomized controlled clinical trials (RCTs), the gold standard to determine treatment efficacy against control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers (DFUs) in comparison to 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. In this study, we 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. 

Methods and Results: The outcomes of 62 patients were analyzed: 31 patients in the vCPM treatment group and 31 patients in the hFDS treatment group. Utilizing a non-inferiority trial design and the established treatment regimen of 8 applications for hFDS, we demonstrated that vCPM was not inferior to hFDS for the proportion of patients achieving complete wound closure (9.68, 90% CI: [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 = 0.0118). For wounds ≤ 5 cm2 average per-patient product costs during the course of treatment were $3,846 and $7,968 (p < 0.0001) for vCPM and hFDS, respectively. 

Conclusion: We demonstrated that vCPM is non-inferior to hFDS with regard to DFU closure when hFDS’s treatment regimen of 8 applications was used, but 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.