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

Randomized controlled clinical trials, the gold standard to determine treatment efficacy against control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers in comparison to standard of care. However, randomized controlled clinical trials comparing efficacy between two or more skin substitutes are very 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 diabetic foot ulcers in a prospective, multicenter, single-blind study. 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, preliminary findings show that vCPM may have better outcomes for wounds5 cm(2): 81.3% (13/16) of wounds in the vCPM group vs. 37.5% (6/16) of wounds in the hFDS group reached complete closure at the end of treatment (p=0.0118). A preliminary product cost analysis for wounds5 cm(2) may show significant savings for patients treated with vCPM. Average per-patient costs during the course of treatment were $3,846 and $7,968 (p<0.0001) for vCPM and hFDS patients, respectively. These results may be used as guidance to wound care providers and payers.