Minimal offloading dressing shows similar healing rates to felted foam for plantar diabetic foot ulcers in pilot trial
Photo by Alexander Grey / Unsplash
Key Takeaway
Consider minimal offloading dressings as an alternative to felted foam for plantar DFUs, but note pilot data show no significant healing time difference.
This pilot randomized controlled trial compared two offloading approaches for plantar diabetic foot ulcers located beneath a metatarsal head. The study enrolled 40 consecutively selected individuals with diabetes and active DFUs at a single center, randomizing them to receive either minimal offloading dressing (MOD) treatments or 15-mm felted foam treatments. The primary outcome was 12-week healing rate, with secondary outcomes including minor or major amputations related to the DFU during a 6-month follow-up period.
For the primary outcome, healing rates at 12 weeks were similar between groups: 19 of 20 patients (95%) in the MOD group healed compared to 17 of 20 patients (85%) in the felted foam group. The median healing time was numerically shorter in the MOD group (14 days, IQR: 7-28 days) compared to the felted foam group (21 days, IQR: 10.5-50 days), but this difference was not statistically significant (P=.292). Secondary amputation outcomes were not reported in the results.
All participants completed the planned study visits during the 12-week follow-up period, though adverse events, serious adverse events, and tolerability were not reported. Key limitations include the pilot nature of the study and small sample size (n=40). The authors suggest MODs should be considered in clinical practice to avoid design mistakes and reduce variability in nonspecialized clinical settings, but these findings should be interpreted cautiously given the study's preliminary nature and lack of statistical significance for the healing time difference.
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View Original Abstract ↓
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.
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