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

Xi Zhang, Hongyan Wang, Chenzhen Du, Xiaoyun Fan, Long Cui, Heming Chen, Fang Deng, Qiang Tong, Min He, Mei Yang, Xingrong Tan, Lin Li, Zerong Liang, Yaqin Chen, Deqing Chen, David G. Armstrong, Wuquan Deng

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)103-109
Number of pages7
JournalDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy
Volume15
DOIs
StatePublished - 2022

Keywords

  • Custom-molded offloading footwear
  • High-risk diabetic foot
  • Patient adherence

ASJC Scopus subject areas

  • Internal Medicine
  • Pharmacology

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