Inforatio Technique and Foot Ulcer Closure Among Patients With Diabetes

Importance Diabetic foot ulcers (DFUs) are common complications of diabetes, a disease increasing in prevalence worldwide. Novel adjunctive treatments that are affordable and feasible to implement in both high- and low-income settings are urgently needed. Objective To assess whether the inforatio technique promotes healing of DFUs compared with standard of care (SOC). Design, Setting, and Participants This multicenter, evaluator-blinded randomized clinical trial was conducted at 4 outpatient clinics specializing in wound care in Denmark from February 15, 2022, to December 18, 2024. One-year medical record follow-up was completed August 14, 2025. Participants included patients with noninfected Wagner grade 1 DFUs. Interventions Participants were randomized 1:1 to receive the inforatio technique every third week for 12 weeks with SOC or SOC only. The inforatio technique involved making incisions on wound beds with 2-mm biopsy punch tools. Main Outcomes and Measures The primary outcome was the proportion of ulcers achieving closure within 20 weeks. Secondary outcomes were health-related and disease-specific quality of life. Safety outcomes included serious and target ulcer–related adverse events. Results A total of 101 patients were randomized, of whom 100 had DFUs and were included in the primary analysis (49 in the inforatio group and 51 in the SOC only group; 85 men; mean [SD] age, 64.4 [11.4] years; median ulcer size, 0.76 [range, 0.09-23.23] cm 2 ). Twenty-four patients in the inforatio group (49.0%) vs 14 in the SOC-only group (27.5%) achieved ulcer closure within 20 weeks (adjusted odds ratio, 3.01 [95% CI, 1.20-7.58]; P = .02). No between-group difference was found in quality of life change from baseline to 20 weeks. Within 20 weeks, 7 patients in the inforatio group vs 13 in the SOC-only group experienced the serious adverse events, including death, amputation, or target ulcer–related hospitalization (relative risk, 0.56 [95% CI, 0.24-1.29]; P = .25), and 16 patients in the inforatio group vs 30 in the SOC-only group experienced target ulcer–related adverse events (relative risk, 0.56 [95% CI, 0.35-0.88]; P = .02). Conclusions and Relevance In this randomized clinical trial, the inforatio technique improved DFU healing compared with SOC alone. Fewer ulcer-related adverse events were also observed with the inforatio technique, although this exploratory finding should be interpreted cautiously. Trial Registration ClinicalTrials.gov Identifier: NCT05189470