30-LB: Multicenter, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot

Abstract

Background: Proper debridement of the wound base is critical to facilitate wound granulation and closure in non-healing diabetic foot ulcers (DFUs) . A unique micro water jet device has been developed that precisely cleans acute and chronic wounds in a tissue-preserving manner while performing a precise mechanical cleaning and stimulation of the wound base to enhance granulation and healing. In this trial the device was used to treat non healing DFUs. Methods: 85 patients were screened, and 50 patients were enrolled for the preliminary analysis, in a two arm randomized controlled trial. Diabetic foot wounds that were non-healing for at least 4 weeks, with adequate blood flow and were void of clinical infection or osteomyelitis were entered into 2 weeks of screening. Those that met all the qualifications were randomized to receive either weekly micro jet wound debridement or standard sharp debridement along with SOC wound dressing and offloading. Both groups were followed for 16 weeks. The study endpoints included healing at 16 weeks as well as percent area wound reduction (PAR) over the treatment phase of 16 weeks. Results: At 16 weeks 72% (18/25) of the Micro Water jet treated DFUs healed compared with 40% (10/25) treated with standard sharp debridement p=0.023 (unadjusted) . Furthermore, at 16 weeks, the percent area reduction (PAR) was 86.5% (SD: 25.60) for the wounds treated with the Micro Water Jet versus 35.1% (SD: 164.47) with standard sharp wound debridement p=0.021 (unadjusted) . The safety analysis showed with regard to wound related adverse events (AE) and serious adverse events (SAE) ; 1 AE and 1 SAE occurring in the Micro Water jet group versus 9 AEs and 4 SAEs in the standard sharp debridement group. Conclusion: The micro water jet device was able to statistically significantly close more refractory DFUs over 16 weeks, with a significant difference in wound area reduction that should be noted. Further evaluation with larger randomized controlled trials are warranted to validate these initial promising findings. Disclosure D. G. Armstrong: None. C. Zelen: Research Support; Geistlich Pharma, Medaxis LLC, Musculoskeletal Transplant Foundation, PolarityTE, Inc. Funding Medaxis LLC (A0010)