(CR-032) A Prospective, Open-Label, Non-Randomized Clinical Trial Using Polyvinyl Alcohol Antibacterial Foam for Debridement in Lower Extremity Wounds

Introduction: Lower extremity wounds are foreboding for patients and can result in chronic inflammation, reduced mobility and chronic pain. These wounds are particularly susceptible to both superficial and deep infection and have high costs associated with care and treatment. Venous leg ulcers are the most common wound type in the United States and affect between 500,000 to 2 million people annually. The diagnosis of venous ulcers is made clinically on the basis of anatomic location, morphology, and a series of characteristic skin changes. The diagnosis is confirmed by the appropriate laboratory studies, which may include functional assessment of the venous system.





Methods: Hydrofera Blue Classic (HFBC) was applied on treatment visits (TVs) 1-4. Application duration was for 30 days, repeated weekly with ulcer and the affected lower extremity evaluated weekly, for 4 weeks, in chart review. At each treatment visit, subject study wounds were analyzed for bacterial fluorescence using the Moleculight i:XÔ (Moleculight, LLC, Toronto, Ontario, Canada). Images were recorded both pre-application and post-application of PVA foam (Hydrofera ClassicÔ). Imaging also collected wound measurements per the Moleculight i:X use indications. Patients were followed at 3 and 6 months for recidivism.

Results: Initial diabetic foot ulcer size was 5.22 cm² (range 1.2 to 9 cm²). After the 4 weeks of therapy with Hydofera Classic, average wound size was reduced 53% to 2.5 cm² (range 0-11.25 cm²). 4 of the 20 subjects achieved complete wound closure at week 4. Median percent area reduction was 39% across all diabetic foot ulcer subjects. 10 of the 20 subjects achieved greater than 40% reduction in ulcer size by week 4. The 3 patients with prior amputations had the lowest percent area reduction of ulcer size (14%, 32% and 34%) compared to subjects without prior amputation

Discussion: The percent area reduction of chronic DFUs in this subject series study was achieved with local surgical debridement and application(s) of a PVA GU/MB foam in patients with advanced age, above-normal BMI and in wounds of greater than 4 weeks non-progressive healing. Further, at 3 and 6 months, 20 of 20 subjects remained closed and did not re-ulcerate. This treatment protocol can be used in varying sites of care to accelerate wound healing in these at-risk diabetic patients.