Custom-Molded Offoading Footwear Effectively Prevents Recurrence and Amputation, and Lowers Mortality Rates in High-Risk Diabetic Foot Patients: A Multicenter, Prospective Observational Study

• Published in: Diabetes, metabolic syndrome and obesity metabolic syndrome and obesity, 2022-01, Vol.15, p.103
• Main Authors: Zhang, Xi, Wang, Hongyan, Du, Chenzhen, Fan, Xiaoyun, Cui, Long, Chen, Heming, Deng, Fang, Tong, Qiang, He, Min, Yang, Mei, Tan, Xingrong, Li, Lin, Liang, Zerong, Chen, Yaqin, Chen, Deqing, Armstrong, David G, Deng, Wuquan
• Format: Article
• Language: English
• Subjects: Amputation; Diabetic foot; Diabetics; Footwear; Health aspects; Medical centers; Medical research; Medicine, Experimental; Patient compliance; Patient education
• ISSN: 1178-7007; 1178-7007

Background: Recurrence of high-risk diabetic feet, after wound, healing is a common challenge among diabetic patients. Continuous use of an offoading device significantly prevents recurrence of high-risk diabetic feet, although patient adherence is imperative to ensuring this therapy's clinical efficacy. In this study, we explored clinical outcomes of patients with a high-risk diabetic foot who had been prescribed with custom-molded offloading footwear under different adherence conditions. Methods: A total of 48 patients (17 females and 31 males) with high-risk diabetic feet, who had been with prescribed offoading footwear in 13 medical centers across 4 cities, were enrolled in the current study. The patients were assigned into either continuous offoading therapy (COT, n = 31) or interrupted offoading therapy (IOT, n = 17) groups, according to their adherence to the therapy. All patients were followed up monthly, and differences in recurrence, amputation, and deaths between the groups were analyzed at 4 months after therapy. Results: Forty-eight patients met our inclusion criteria and were therefore included in the final analysis. Among them, 31 were stratifed into the COT group and adhered to offoading therapy throughout the study period, whereas 17 were grouped as IOT and exhibited interrupted adherence to offoading therapy. We found statistically significant differences in recurrence rates (0 vs 38.46%, p < 0.01), amputation (0 vs 11.76%, p < 0.01), and deaths (0% vs 5.88%, p < 0.01) between the groups during follow-up. Conclusion: Patients' adherence is imperative to efficacy of custom-molded offoading footwear during treatment of high-risk diabetic foot. Further studies are needed to elucidate the role of improved design of the offoading device and the need for enhanced patient education for improved adherence. Keywords: custom-molded offoading footwear, high-risk diabetic foot, patient adherence