Clinical Efficacy of a Novel Minimal Offloading Dressing for the Treatment of Plantar Diabetes-Related Foot Ulcers: A Pilot Randomized Controlled Clinical Trial

OBJECTIVE: To evaluate the clinical efficacy of a minimal offloading dressing (MOD) in comparison with felted foam for the treatment of diabetes-related foot ulcers (DFU) located beneath a metatarsal head. METHODS: A monocenter randomized controlled parallel (1:1) clinical trial was performed with consecutively selected individuals with diabetes and active DFUs. Participants were randomly assigned to control or treatment groups. The experimental group received MOD treatments, and the control group received 15-mm felted foam treatments. All participants wore a removable ankle-high offloading device. The primary outcome measure was the 12-week healing rate. The time to healing was evaluated during a 12-week follow-up period. The secondary outcome measures included minor or major amputations related to the DFU during a follow-up period of 6 months. RESULTS: Between December 2023 and September 2024, 40 participants (20 per group) were enrolled. All participants completed the planned study visits during the 12-week follow-up period. Of the total sample, 36 participants (90%) healed during the follow-up period. There were 17 participants (85%) who healed in the control group, whereas 19 participants (95%) healed in the experimental group. The median healing time was 21 days [interquartile range (IQR): 10.5-50 d] in the control group and 14 (7-28) days in the experimental group ( P =.292). CONCLUSIONS: The use of MOD in combination with an ankle-high offloading device resulted in similar healing rates compared with felted foam at 12 weeks. MODs should be considered in clinical practice to avoid design mistakes and reduce the variability in nonspecialized clinical settings.