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

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 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 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.

Keywords:

• custom-molded offloading footwear
• high-risk diabetic foot
• patient adherence

Data Sharing Statement

The data are available on reasonable request from the corresponding author ([email protected]).

Ethics Approval and Informed Consent

The study complied with the Declaration of Helsinki. The study, named Footwear and Offloading Optimum Therapy (FOOT) study, was approved by the institutional review board (IRB) of Chongqing University Central Hospital (ChiCTR1900022468). All protocols were conducted in accordance with the declaration of Helsinki. All participants provided written informed consent to participate in the study.

Acknowledgments

We thank all the participants in the present study for their participation and valuable feedbacks. This research was funded by the Joint Medical Research Programs of Chongqing Science and Technology Bureau and Health Commission Foundation (Grant No. 2020GDRC023), the Science and Technology Research Program of Chongqing Municipal Education Commission (Grant No. KJQN201900101), the Natural Science Foundation of Chongqing Municipal Science and Technology Bureau (cstc2020jcyj-msxmX0298). This study is partially supported by National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases Award Number 1R01124789-01A1 and National Science Foundation (NSF) Center to Stream Healthcare in Place (#C2SHiP) CNS Award Number 2052578 awarded to Prof. Armstrong DG.

Disclosure

The authors report no conflicts of interest in this work.