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

Not Applicable

Completed

• Conditions: Diabetic Foot; Neuropathy; Quality of Life
• Interventions: Other: 55 shore Custom made insole; Other: Custom made insoles 35 shore; Other: Prefabricated insoles

• Registration Number: NCT01663519
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-02
• Study Completion: 2012-07
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-13
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

• Ulcers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
55 shore Custom made insoles	55 shore Custom made insole	Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
Custom made insoles 35 shore	Custom made insoles 35 shore	Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
Prefabricated insoles	Prefabricated insoles	Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.

Primary Outcome Measures

Name	Time	Method
In shoe plantar pressure measurement	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Gait analysis	every 6 months until 24 months is reached	Optical tracking system with skin-mounted markers

Trial Locations

Locations (1)

Lundbergs Laboratory for Orthopaedic Research; 🇸🇪 Gothenburg, Sweden