Diabetic foot ulcers (DFUs), especially plantar ulcers, are challenging to manage in settings with limited resources because standard offloading devices are often costly, scarce, or require specialised expertise. The study evaluated a low-cost offloading device, Toa Uzito, developed to address this treatment gap and assessed whether its use improved healing outcomes for patients with plantar DFUs.
A matched case-control clinical study was conducted at a specialised diabetic foot centre in Dar es Salaam, Tanzania. The investigation focused on real-world effectiveness of the low-cost device in a resource-limited clinical environment.
The study enrolled patients who had a single plantar diabetic foot ulcer. A total of 621 patients were included: 128 in the intervention group who received the Toa Uzito device and 493 matched controls who received standard care without offloading. Controls were matched to intervention patients by age, body mass index (BMI), and duration of diabetes.
The intervention consisted of treatment with the low-cost Toa Uzito offloading device. The source describes the device as an affordable and simple offloading option intended to reduce plantar pressure and promote ulcer healing where conventional devices are inaccessible or unaffordable.
Control participants received standard care for plantar DFU but did not receive offloading with Toa Uzito. Standard care details beyond the lack of offloading were not described in the abstract.
The primary outcome was time to complete ulcer healing. Healing outcomes were analysed using Kaplan–Meier survival analysis and Cox regression. The authors also performed stratified analyses by SINBAD ulcer classification to examine efficacy across ulcer severity categories.
Across a mean follow-up of 133.8 days, the Toa Uzito intervention group showed superior healing outcomes compared with controls:
Statistical testing indicated significantly superior healing efficacy for Toa Uzito after stratification by SINBAD classification (χ2 = 71.2, p < 0.01).
The study included stratified analysis using the SINBAD ulcer classification. After stratification, Toa Uzito demonstrated significantly better healing outcomes compared with standard care (χ2 = 71.2, p < 0.01), indicating the device's effect persisted across categorized ulcer severity in the reported analysis.
Based on the reported data, the low-cost Toa Uzito device significantly improved healing rates and reduced time to healing for plantar DFUs in this matched case-control cohort from Tanzania. The authors highlight affordability and simplicity as key advantages supporting its use as an effective offloading strategy in resource-limited settings where conventional devices may be unavailable or unaffordable.
Limitations and details not reported in the abstract: the source abstract does not provide granular information on the exact nature of standard care provided to controls, device design specifics, adherence rates, adverse events, or full Cox regression results and hazard ratios. Those details were not reported in the abstract and would require consultation of the full article for comprehensive assessment.
Overall, the presented findings support consideration of low-cost offloading solutions like Toa Uzito to improve DFU outcomes where standard devices are inaccessible, while acknowledging that full trial details and external validation would strengthen generalisability.