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

NCT01663519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2019-07-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Roy Tranberg, PhD · Lundbergs laboratory for Orthopaedic Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-02-29
Completion
2012-07-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01663519 on ClinicalTrials.gov