NCT01663519

Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg

Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the feet, education and prescription of insoles in combination with well fitting shoes are supposed to decrease the risk of ulcers and prevent amputation. Further research is, however, needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this study is to compare three different types of insoles with respect to pressure distribution. Every 6 months follow-up is assessed until 24 months is reached.

Detailed description

Patients included in the study were randomized into 3 different groups. Group number 1 and 2 got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55 shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. All patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. One and the same technician made the casting and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks after the first visit. At deliverance base line measurement was assessed.

Conditions

• Diabetic Foot
• Neuropathy
• Quality of Life

Interventions

Type	Name	Description
OTHER	Custom made insoles 35 shore	Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
OTHER	Prefabricated insoles	Prefabricated insoles
OTHER	55 shore Custom made insole	Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-02-01
• Completion: 2012-07-01
• First posted: 2012-08-13
• Last updated: 2019-07-29

Locations

1 site across 1 country: Sweden