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

Overview

Journal Diabetes Metab Syndr Obes

Publisher Dove Medical Press

Specialty Endocrinology

Date 2022 Jan 20

PMID 35046681

Authors

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

Affiliations

Soon will be listed here.

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.

Citing Articles

Gaussian barebone mechanism and wormhole strategy enhanced moth flame optimization for global optimization and medical diagnostics.

Ma J, Zhao Z, Zhang L PLoS One. 2025; 20(1):e0317224.

PMID: 39820167 PMC: 11737686. DOI: 10.1371/journal.pone.0317224.

Prototyping and Experimental Analysis of Active Offloading Footwear for Patients With Diabetes Using an Array of Magnetorheological Fluid-Based Modules.

Tiwari B, Germano P, Hemler S, Koechli C, Pataky Z, Civet Y J Diabetes Sci Technol. 2024; :19322968241260037.

PMID: 38887019 PMC: 11571706. DOI: 10.1177/19322968241260037.

Transforming the Management of Articular Fractures in the Foot: A Critical Examination of Current Methods and Future Directions: A Review.

Dobrota R, Barbilian A, Sporea C, Ferechide D J Pers Med. 2024; 14(5).

PMID: 38793107 PMC: 11122118. DOI: 10.3390/jpm14050525.

The Validity and Efficacy of a Preventative Intervention Model for Reducing Ulcer Recurrence in Diabetic Patients in Indonesia.

Jais S, Pratama K, Pradika J, Haryanto H SAGE Open Nurs. 2023; 9:23779608231179549.

PMID: 37334064 PMC: 10272669. DOI: 10.1177/23779608231179549.

A New Fast Control Strategy of Terminal Sliding Mode with Nonlinear Extended State Observer for Voltage Source Inverter.

Zhang C, Xu D, Ma J, Chen H Sensors (Basel). 2023; 23(8).

PMID: 37112292 PMC: 10142547. DOI: 10.3390/s23083951.

References

Gao Y, Wang C, Chen D, Huang H, Chen L, Liu G . Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial. Trials. 2021; 22(1):151. PMC: 7890642. DOI: 10.1186/s13063-021-05098-8. View

Chantelau E, Haage P . An audit of cushioned diabetic footwear: relation to patient compliance. Diabet Med. 1994; 11(1):114-6. DOI: 10.1111/j.1464-5491.1994.tb00240.x. View

Du C, Wang H, Chen H, Fan X, Liu D, Du D . The Feasibility and Effectiveness of Wearable Sensor Technology in the Management of Elderly Diabetics with Foot Ulcer Remission: A Proof-Of-Concept Pilot Study with Six Cases. Gerontology. 2021; 67(4):493-502. DOI: 10.1159/000513729. View

Armstrong D, Boulton A, Bus S . Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017; 376(24):2367-2375. DOI: 10.1056/NEJMra1615439. View

Bus S, Waaijman R, Arts M, de Haart M, Busch-Westbroek T, Van Baal J . Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care. 2013; 36(12):4109-16. PMC: 3836114. DOI: 10.2337/dc13-0996. View

Jarl G, Alnemo J, Tranberg R, Lundqvist L . Gender differences in attitudes and attributes of people using therapeutic shoes for diabetic foot complications. J Foot Ankle Res. 2019; 12:21. PMC: 6440011. DOI: 10.1186/s13047-019-0327-0. View

Johnson M, Newton P, Goyder E . Patient and professional perspectives on prescribed therapeutic footwear for people with diabetes: a vignette study. Patient Educ Couns. 2006; 64(1-3):167-72. DOI: 10.1016/j.pec.2005.12.013. View

Maciejewski M, Reiber G, Smith D, Wallace C, Hayes S, Boyko E . Effectiveness of diabetic therapeutic footwear in preventing reulceration. Diabetes Care. 2004; 27(7):1774-82. DOI: 10.2337/diacare.27.7.1774. View

Boulton A . The diabetic foot: from art to science. The 18th Camillo Golgi lecture. Diabetologia. 2004; 47(8):1343-53. DOI: 10.1007/s00125-004-1463-y. View

10.

Bus S, Van Netten J, Lavery L, Monteiro-Soares M, Rasmussen A, Jubiz Y . IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2015; 32 Suppl 1:16-24. DOI: 10.1002/dmrr.2696. View

11.

Hingorani A, LaMuraglia G, Henke P, Meissner M, Loretz L, Zinszer K . The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016; 63(2 Suppl):3S-21S. DOI: 10.1016/j.jvs.2015.10.003. View

12.

Jiang X, Li N, Yuan Y, Yang C, Chen Y, Ma Y . Limb Salvage and Prevention of Ulcer Recurrence in a Chronic Refractory Diabetic Foot Osteomyelitis. Diabetes Metab Syndr Obes. 2020; 13:2289-2296. PMC: 7335304. DOI: 10.2147/DMSO.S254586. View

13.

Wooldridge J, Bergeron J, Thornton C . Preventing diabetic foot disease: lessons from the Medicare therapeutic shoe demonstration. Am J Public Health. 1996; 86(7):935-8. PMC: 1380433. DOI: 10.2105/ajph.86.7.935. View

14.

Waaijman R, Keukenkamp R, de Haart M, Polomski W, Nollet F, Bus S . Adherence to wearing prescription custom-made footwear in patients with diabetes at high risk for plantar foot ulceration. Diabetes Care. 2013; 36(6):1613-8. PMC: 3661819. DOI: 10.2337/dc12-1330. View

15.

Lazzarini P, Pacella R, Armstrong D, Van Netten J . Diabetes-related lower-extremity complications are a leading cause of the global burden of disability. Diabet Med. 2018; . DOI: 10.1111/dme.13680. View

16.

Pickwell K, Siersma V, Kars M, Holstein P, Schaper N . Diabetic foot disease: impact of ulcer location on ulcer healing. Diabetes Metab Res Rev. 2013; 29(5):377-83. DOI: 10.1002/dmrr.2400. View

17.

Bus S . Priorities in offloading the diabetic foot. Diabetes Metab Res Rev. 2012; 28 Suppl 1:54-9. DOI: 10.1002/dmrr.2240. View

18.

Ha Van G, Siney H, Hartmann-Heurtier A, Jacqueminet S, Greau F, Grimaldi A . Nonremovable, windowed, fiberglass cast boot in the treatment of diabetic plantar ulcers: efficacy, safety, and compliance. Diabetes Care. 2003; 26(10):2848-52. DOI: 10.2337/diacare.26.10.2848. View

19.

Jiang X, Yuan Y, Ma Y, Zhong M, Du C, Boey J . Pain Management in People with Diabetes-Related Chronic Limb-Threatening Ischemia. J Diabetes Res. 2021; 2021:6699292. PMC: 8128546. DOI: 10.1155/2021/6699292. View

20.

Turns M . The diabetic foot: an overview for community nurses. Br J Community Nurs. 2012; 17(9):422, 424-27, 430-3. DOI: 10.12968/bjcn.2012.17.9.422. View