A multicenter, randomized, controlled study is currently evaluating the safety and efficacy of BR-AM plus standard of care versus standard of care only in the treatment of diabetic foot ulcers (DFUs). The trial aims to control potential variables affecting outcomes by standardizing requirements for debridement, wound dressings, and offloading. Weekly visits will monitor compliance in wound care and off-loading, and document wound closure.
- Crossover Treatment Phase: Patients who do not achieve complete wound closure after 12 weeks of standard care will be allowed to crossover to receive BR-AC for an additional 12 weeks.
- Patient Population: The study focuses on patients with DFUs having adequate perfusion without clinical signs and symptoms of infection.
- Historical Data: Approximately 30% of DFUs heal within 12 weeks using standard care alone, but around half of patients require advanced therapy.
- Hypothesis: Weekly applications of BR-AM (Vendaje®) to nonhealing DFUs are expected to result in a higher rate of complete healing within 12 weeks compared to standard care alone.
- Follow-up Phase: A four-week follow-up period will assess the longevity and durability of the closed wound for all subjects achieving complete wound closure.
This study represents a significant step forward in the treatment of diabetic foot ulcers, offering hope for improved healing rates and outcomes for patients suffering from this challenging condition.
