Collagen-based dressings for diabetic foot ulcers: A systematic review.

Background: To evaluate the efficacy and safety of collagen-based dressings in the management of diabetic foot ulcers (DFUs), compared to standard wound care (SWC), human amniotic membrane allografts (hAMA), and decellularized extracellular matrix (dECM) products. Methods: A systematic review of randomized controlled trials (RCTs) and cohort studies published between December 2013 and March 2025 was conducted using PubMed, Scopus, and Web of Science. Eligible studies assessed collagen-based dressings for DFUs, with primary outcomes including wound area reduction, closure rates, and healing time. Adverse events were considered secondary outcomes. Due to heterogeneity, findings were narratively synthesized by dressing type. Results: Twenty-two studies (15 RCTs, 7 cohort studies) were included. Collagen-based dressings consistently outperformed SWC, achieving greater wound reduction (54.5--88.2%), higher closure rates (22.2--82.4%), and shorter healing times (21--83.5 days), with no serious treatment-related adverse events. Helicoll showed superior performance (wound reduction: 84--86.5%; closure: 50--71.4%). Comparisons with hAMA and dECM yielded mixed and heterogeneous results, without consistent evidence of superiority. RCTs favored hAMA over Apligraf, while some real-world studies reported the opposite. Findings on collagen/ORC/silver dressings versus dECM were also inconsistent. Conclusions: Collagen-based dressings are safe and effective for improving DFU healing when compared with standard wound care. However, current evidence is insufficient and heterogeneous to establish superiority over other advanced biologic therapies. Further head-to-head randomized trials are warranted.