Matched case-control study demonstrates faster healing with a low-cost offloading device in diabetic foot ulcer patients, highlighting an effective strategy for resource-limited settings.
Key Points
To evaluate the effectiveness of the low-cost Toa Uzito offloading device in improving time to complete healing for patients with plantar diabetic foot ulcers.
Matched case–control clinical study conducted at a specialized diabetic foot center in Dar es Salaam, Tanzania, enrolling 621 patients with a single plantar diabetic foot ulcer (128 intervention, 493 controls) with a mean follow-up of 133.8 days.
The intervention group received the Toa Uzito device, while controls received standard care without offloading, matched on age, body mass index, and diabetes duration.
Complete ulcer healing was assessed using Kaplan-Meier survival analysis and Cox regression, including stratification by SINBAD classification.
Ulcer healing rates were higher in the intervention group than in controls at 12 weeks (44.9% vs. 34.9%) and 24 weeks (85.0% vs. 75.2%).
Intervention patients achieved a shorter mean healing time compared to controls (125.7 vs. 137.5 days), with complete healing achieved in all intervention patients.
Toa Uzito demonstrated superior healing efficacy across ulcer severity grades stratified by SINBAD classification (χ² = 71.2, p < 0.01).