Comparative Effectiveness of a Human Fibroblast-derived Dermal Substitute versus a Fetal Bovine Collagen Dressing for the Treatment of Diabetic Foot Ulcers in a Real-world Setting

Background: This was a retrospective comparative effectiveness research (CER) study to evaluate the clinical outcomes of a human fibroblast-derived dermal substitute (HFDS) and a fetal bovine collagen dressing (FBCD) for the treatment of diabetic foot ulcers (DFUs).

Methods: Using a wound-care specific electronic record database, we assessed real-world outcomes in 4,057 patients with 4,960 DFUs receiving treatment at 258 wound care centers. The analysis included DFUs ≥ 1 and < 40 cm² at the time of the first study treatment (N = 4,521, HFDS; N = 439, FBCD). The average baseline areas and durations were 4.5 cm² and 7.3 months for HFDS compared to 6.9 cm² and 8.9 months for FBCD. A Cox model was used to adjust for covariates that included area and duration.

Results: The median time to wound closure for HFDS-treated wounds was 30% faster than for FBCD-treated wounds (12 weeks versus 17.1 weeks), and the proportion of wounds that achieved wound closure was significantly greater for HFDS by 8 weeks (35% versus 28%), 12 weeks (49% versus 40%), and 24 weeks (70% versus 60%); P<0.0001. Treatment with a bioengineered cellular technology increased the probability of healing by 31% compared to a bovine collagen dressing; Hazard Ratio = 1.31 [95% Confidence Interval (1.14, 1.49)], P<0.0001.

Conclusion: We conclude that these data demonstrated that HFDS treatment significantly increased the probability, frequency, and speed of wound closure when compared to FBCD in a real-world setting.