TY - JOUR
T1 - Custom-Molded Offloading Footwear Effectively Prevents Recurrence and Amputation, and Lowers Mortality Rates in High-Risk Diabetic Foot Patients
T2 - A Multicenter, Prospective Observational Study
AU - Zhang, Xi
AU - Wang, Hongyan
AU - Du, Chenzhen
AU - Fan, Xiaoyun
AU - Cui, Long
AU - Chen, Heming
AU - Deng, Fang
AU - Tong, Qiang
AU - He, Min
AU - Yang, Mei
AU - Tan, Xingrong
AU - Li, Lin
AU - Liang, Zerong
AU - Chen, Yaqin
AU - Chen, Deqing
AU - Armstrong, David G.
AU - Deng, Wuquan
N1 - Publisher Copyright:
© 2022 Zhang et al.
PY - 2022
Y1 - 2022
N2 - Background: Recurrence of high-risk diabetic feet, after wound, healing is a common challenge among diabetic patients. Continuous use of an offloading 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 off-loading 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 offloading footwear in 13 medical centers across 4 cities, were enrolled in the current study. The patients were assigned into either continuous offloading therapy (COT, n = 31) or interrupted offloading 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 stratified into the COT group and adhered to offloading therapy throughout the study period, whereas 17 were grouped as IOT and exhibited interrupted adherence to offloading 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 offloading footwear during treatment of high-risk diabetic foot. Further studies are needed to elucidate the role of improved design of the offloading device and the need for enhanced patient education for improved adherence.
AB - Background: Recurrence of high-risk diabetic feet, after wound, healing is a common challenge among diabetic patients. Continuous use of an offloading 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 off-loading 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 offloading footwear in 13 medical centers across 4 cities, were enrolled in the current study. The patients were assigned into either continuous offloading therapy (COT, n = 31) or interrupted offloading 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 stratified into the COT group and adhered to offloading therapy throughout the study period, whereas 17 were grouped as IOT and exhibited interrupted adherence to offloading 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 offloading footwear during treatment of high-risk diabetic foot. Further studies are needed to elucidate the role of improved design of the offloading device and the need for enhanced patient education for improved adherence.
KW - Custom-molded offloading footwear
KW - High-risk diabetic foot
KW - Patient adherence
UR - https://www.scopus.com/pages/publications/85124372518
UR - https://www.scopus.com/pages/publications/85124372518#tab=citedBy
U2 - 10.2147/DMSO.S341364
DO - 10.2147/DMSO.S341364
M3 - Article
AN - SCOPUS:85124372518
SN - 1178-7007
VL - 15
SP - 103
EP - 109
JO - Diabetes, Metabolic Syndrome and Obesity
JF - Diabetes, Metabolic Syndrome and Obesity
ER -