Custom-Molded Offloading Footwear Effectively Prevents Recurrence and Amputation, and Lowers Mortality Rates in...

Area of Science:

• Podiatry
• Diabetology
• Clinical Medicine

Background:

• High-risk diabetic foot recurrence post-wound healing is a significant clinical challenge.
• Offloading devices are vital for preventing recurrence, but patient adherence is key to their effectiveness.
• This study investigated clinical outcomes based on adherence to custom-molded offloading footwear.

Purpose of the Study:

• To evaluate the clinical outcomes of high-risk diabetic foot patients based on adherence to custom-molded offloading footwear.
• To compare recurrence, amputation, and mortality rates between continuous and interrupted offloading therapy groups.

Main Methods:

• 48 high-risk diabetic foot patients were enrolled across 13 medical centers.
• Patients were divided into continuous offloading therapy (COT, n=31) and interrupted offloading therapy (IOT, n=17) groups based on adherence.
• Outcomes including recurrence, amputation, and deaths were analyzed at 4 months.

Main Results:

• Continuous offloading therapy (COT) showed significantly lower recurrence rates (0%) compared to interrupted offloading therapy (IOT) (38.46%, p < 0.01).
• Amputation rates were significantly lower in the COT group (0%) versus the IOT group (11.76%, p < 0.01).
• Mortality rates were also significantly reduced in the COT group (0%) compared to the IOT group (5.88%, p < 0.01).

Conclusions:

• Patient adherence to custom-molded offloading footwear is essential for successful high-risk diabetic foot treatment.
• Interrupted adherence significantly increases risks of recurrence, amputation, and death.
• Further research should focus on improving offloading device design and patient education to enhance adherence.