Comparative effectiveness of a human fibroblast-derived dermal substitute and a viable cryopreserved placental membrane for the treatment of diabetic foot ulcers.

Objective

To compare a human fibroblast-derived dermal substitute (HFDS) to a viable cryopreserved placental membrane (vCPM) for use in diabetic foot ulcers (DFUs).

Methods

An electronic medical record database of 1622 refractory DFUs with areas 1-40 cm2 was analyzed.

Results

Cox estimates of wound closure for HFDS (1444 wounds) were significantly greater (p = 0.0002) by weeks 12 (31 vs 21%), 24 (55 vs 39%) and 36 (68 vs 51%) compared with vCPM (178 wounds). HFDS reduced the median time to wound closure by 55% compared with vCPM, (20 vs 36 weeks, p = 0.0002). HFDS also increased the probability of wound closure by 60% (hazard ratio = 1.60 [95% confidence interval, (1.25, 2.06)], p = 0.0002).

Conclusion

HFDS improved time and frequency of wound closure in DFUs versus vCPM.