(CR-055) Novel Wound Matrix Shows Significant Percent Area Reduction at 4 and 12 Weeks over Standard of Care in Clinical Study of Diabetic Foot Ulcers

Mary Cheney, APRN, CNP, CWS, COCN – ProMedica Jobst Wound Care; Susan Shuman, BSN, RN – ProMedica Jobst Wound Care; Suzanne Bakewell, PhD – Omeza; Desmond Bell, DPM, CWS, FFPM RCPS (Glasg) – Omeza

Introduction: Diabetic foot ulcers (DFUs) are a common type of chronic wound among patients with diabetes and are associated with an increased risk of amputation.^1,2 A novel combination therapy developed to manage chronic wounds comprises a wound therapy formulation (OCM), a wound preparation formulation, and a skin protectant formulation. One goal of this study is to demonstrate that the combination therapy with standard of care (SOC) moves chronic DFUs from a stalled state to a healing state in a 4-week period (NCT05417425).

Methods: Adult (≥21-year-old) patients with Type 1 or 2 diabetes and a DFU (Wagner grade 1 or 2) of at least 1-month duration at date of signed consent were eligible for participation. During the 4-week treatment phase, patients’ DFUs were managed with combination therapy and SOC (off-loading). At the end of the treatment visits, patients whose DFUs had not healed had the option of continuing therapy for up to 8 weeks. Endpoints included 4- and 12-week percent area reduction (PAR). Patients with DFUs managed with SOC only (n=6) served as historical controls.

Results: At final analysis (N=19), median age was 60 years (range, 44-85), and median wound duration was 36 weeks (range, 4-72). Five patients included in the analysis did not complete the study (4 patients were terminated/withdrawn by the investigator, and 1 patient died from comorbidities before end of study). Median wound size was 1.4cm² (range, 0.37-25.0) at treatment visit (TV) 1 and 0.68cm² (range, 0-10.06) at TV5. Average 4-week PAR was 60%, with 3 patients experiencing 100% closure. At TV12, median wound size was 0.0cm² (range, 0-2.59), and average PAR was 93%, with 5 additional patients experiencing 100% closure. Average 4- and 12-week PARs with SOC alone were 42% and 45%, respectively.

Discussion: These results show encouraging healing rates (60% 4-week PAR and 93% 12-week PAR) of DFUs managed with the combination therapy and SOC. Clinical trials evaluating the combination therapy in VLUs (NCT05291169) and multiple wound types (NCT05921292) are underway.

Previous Presentation: EWMA Congress (May 1-3, 2024)