A Feasibility Study on the Efficacy of a Patient-Owned Wound Surveillance System for Diabetic Foot Ulcer Care (epows Study)

ObjectiveWound image analysis tools hold promise in helping patients to monitor their wounds. We aim to perform a novel feasibility study on the efficacy of a patient-owned wound surveillance system for diabetic foot ulcer (DFU) care.MethodsThis two-institutional, prospective, single-arm pilot study examined patients with DFU. An artificial intelligence-enabled image analysis app calculating the wound surface area was installed and patients or caregivers were instructed to take pictures of wounds during dressing changes. Patients were followed until wound deterioration, wound healing, or wound stability at 6 months occurred and the outcomes of interest included study adherence, algorithm performance, and user experience.ResultsBetween January 2021 and December 2021, 39 patients were enrolled in the study, with a mean age of 61.6 +/- 8.6 years, and 69% (n = 27) of subjects were male. All patients had documented diabetes and 85% (n = 33) of them had peripheral arterial disease. A mean follow-up for those completing the study was 12.0 +/- 8.5 weeks. At the conclusion of the study, 80% of patients (n = 20) had primary wound healing whilst 20% (n = 5) had wound deterioration. The study completion rate was 64% (n = 25). Usage of the app for surveillance of DFU healing, as compared to physician evaluation, yielded a sensitivity of 100%, specificity of 20%, positive predictive value of 83%, and negative predictive value of 100%. Of those who provided user experience feedback, 59% (n = 10) felt the app was easy to use, 47% (n = 8) would recommend the wound analysis app to others but only 6% would pay for the app out of pocket (n = 1).ConclusionImplementation of a patient-owned wound surveillance system is feasible. Most patients were able to effectively monitor wounds using a smartphone app-based solution. The image analysis algorithm demonstrates strong performance in identifying wound healing and is capable of detecting deterioration prior to interval evaluation by a physician. Patients generally found the app easy to use but were reluctant to pay for the use of the solution out of pocket.