Endocrinology · General Practice ·
Inforum technique increased diabetic foot ulcer closure in randomized trial
A multicenter, evaluator-blinded randomized trial in Denmark compared the inforatio technique plus standard care with standard care alone in 100 patients with noninfected Wagner grade 1 diabetic foot ulcers. More ulcers closed within 20 weeks in the inforatio group, while quality-of-life changes did not differ between groups.
- Ulcer closure: 49.0% with inforatio versus 27.5% with standard care.
- Quality-of-life changes did not differ between groups.
- Adverse-event findings require cautious interpretation.
This multicenter, evaluator-blinded randomized clinical trial enrolled patients with noninfected Wagner grade 1 diabetic foot ulcers at four outpatient wound-care clinics in Denmark. Participants were assigned to standard care (SOC) with or without the inforatio technique, which uses 2-mm biopsy punches to make incisions in the wound bed every three weeks for 12 weeks. The primary outcome was ulcer closure within 20 weeks. Of 101 randomized patients, 100 were included in the primary analysis.
By 20 weeks, ulcers had closed in 24 of 49 patients (49.0%) receiving inforatio plus SOC and 14 of 51 (27.5%) receiving SOC alone (adjusted odds ratio, 3.01; 95% CI, 1.20-7.58; P = .02). Quality-of-life changes did not differ between groups. Target ulcer-related adverse events were reported in 16 versus 30 patients (relative risk, 0.56; 95% CI, 0.35-0.88; P = .02). Serious adverse events occurred in 7 versus 13 patients; this difference was not statistically significant.
The results suggest improved short-term ulcer closure in this trial population, but applicability to infected or more severe ulcers and other care settings is not established. The authors characterize the adverse-event finding as exploratory; the study does not establish effects beyond the reported follow-up or support conclusions about quality of life.
In practice
For patients with noninfected Wagner grade 1 diabetic foot ulcers similar to those treated in this Danish multicenter trial, adding the inforatio technique to standard care was associated with greater ulcer closure by 20 weeks than standard care alone (49.0% vs 27.5%). This is evidence from a randomized trial, but it does not establish effectiveness for infected or more severe ulcers, other care settings, or longer-term outcomes. Quality of life did not differ, and the reported reduction in ulcer-related adverse events was exploratory.
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JAMA Network Open: Inforatio Technique and Foot Ulcer Closure Among Patients With Diabetes ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.