Real-World Comparative Effectiveness Assessment Study of a Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial and a Cryopreserved Cadaveric Skin Allograft for Use in Diabetic Foot Ulcers - A Non-inferiority Analysis.

Objective: To determine the effectiveness of a native type I collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) and a cryopreserved cadaveric skin allograft (CCSA) for use in diabetic foot ulcers (DFUs).

Methods: A real-world data study was conducted on 989 DFUs analyzed digitally. Of these, 325 and 664 DFUs were treated with PCMP and CCSA, respectively. Non-inferiority testing for equivalence of PCMP and CCSA was performed at a level of significance of < .05.

Results: Cox proportional hazards regression analysis for healing for PCMP and CCSA at weeks 4, 8, 12, and 24 was 12% vs 10%, 27% vs 24%, 39 % vs 37%, and 60% vs. 64%, respectively. No statistically significant differences were shown; = .95. The median time to healing was 18 and 17 weeks for PCMP and CCSA, respectively; = .95. The probability of healing was statistically equivalent between PCMP and CCSA; hazard ratio = 0.99; 95% CI (0.85, 1.17). Non-inferiority statistical testing results showed = .01.

Conclusions: Using non-inferiority hypothesis testing at a level of significance of <.05, we showed that PCMP was equivalent to CCSA; = .01. PCMP vs CCSA demonstrated no statistically significant differences in median time, percentage, and probability of healing. Data from real-world data comparative effectiveness assessment studies can help guide clinicians to limit overuse of ineffective therapies and underuse of effective therapies.