Collagen Dressing in the Treatment of Diabetic Foot Ulcer: A Prospective, Randomized, Placebo-Controlled, Single-Center Study

Abstract

Aims: Because collagen is fundamental to wound healing and skin formation, collagen-containing dressing materials might be beneficial in treating diabetic foot ulcers (DFU), but supporting evidence is needed. Here, we examined the effectiveness and safety of collagen dressing material in DFU treatment.

Methods: This prospective, randomized, placebo-controlled, single-center study included patients with type 1 or 2 diabetes and palpable foot pulse who had Wagner grade 1 or 2 ulcers ≥1.0 cm2 with no signs of healing for ≥6 weeks. Patients were treated with foam dressing alone (control group) or with a porcine type I collagen dressing material (collagen group). Complete ulcer healing rate was the primary endpoint, and healing velocity and time to 50% size reduction were secondary endpoints.

Results: Thirty patients were included (collagen group: 17, control group: 13). There were no significant differences in demographic factors or baseline DFU characteristics. Compared to the control group, the collagen group presented a higher rate of complete healing [82.4% vs. 38.5%, P = .022], faster healing velocity (P < .05), and shorter median time to 50% size reduction (21 versus 42 days; hazard ratio = 1.94, P < .05).

Conclusions: Wound management using collagen materials in DFUs showed faster and complete healing rate.