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A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration

NCT00999635 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2009-10-27

No results posted yet for this study

Summary

Importance of the topic:

Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One method of reducing the risk of ulceration in the neuropathic foot is through the provision of therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is currently based on anecdotal evidence. The idea held by many practitioners that the custom made insole is superior in its effect remains speculation, unsupported by the evidence. In the absence of economic analysis, the available data suggests that the custom insole is substantially more expensive to the NHS. This study, to determine which of two types of insole used in therapeutic shoes reduces peak pressure more in the at-risk diabetic foot, is therefore a very important topic and will provide both useful evidence for the NHS podiatry services. It is of course also very important for patients with diabetes as the personal suffering of those undergoing amputation is immense.

The study is a single blind randomised controlled trial comparing custom made with 'off the shelf' insoles.

Conditions

Interventions

DEVICE

Insole

Comparison of custom made and prefabricated insoles designed for the neuropathic diabetic foot, issued for day time wear and followed for a 6 month period

Sponsors & Collaborators

  • Cornwall and Illes of Scilly Primary Care Trust

    collaborator UNKNOWN

  • Plymouth Teaching Primary Care Trust

    collaborator UNKNOWN

  • Diabetes UK

    collaborator OTHER

  • University of Plymouth

    lead OTHER

Principal Investigators

  • Ray Jones, Professor · University of Plymouth

  • Joanne Paton, PhD · University of Plymouth

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-09-30
Completion
2008-09-30

Countries

  • United Kingdom

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 NCT00999635 on ClinicalTrials.gov