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Evaluation of Education in the Secondary Prevention of Foot Ulceration in Diabetes

NCT00729456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2008-08-07

No results posted yet for this study

Summary

This study was an attempt to confirm the results of an earlier experiment in which the benefit of an education programme was assessed in a group of people with diabetes complicated by ulceration of the foot. Foot ulcers are the source of considerable suffering and cost and carry a high risk of amputation: they are difficult to heal and approximately 40% recur in the first 12 months. The earlier experiment (published by Malone and colleagues in 1989) indicated that a single hour-long education session appeared to lead to a three-fold reduction in the numbers of ulcers which recurred after successful treatment. It was not possible to confirm these findings in the present study in which patients from three specialist clinics in Nottingham and Derby, UK, were allocated either to receive a one-to-one, individually targeted, education programme in the own home (and reinforced after one month by a telephone call), or to receive usual care. The group who received the education reported better recommended foot care behaviour (intended to minimise the risk of injury) at 12 months but despite this, there was no difference between the two groups in the percentage who suffered either a new ulcer (41% education versus 41% usual care) or amputation (10% and 11%, respectively). While the benefit of education is undeniable in general, it was not possible to show that this particular teaching session had an impact on the occurrence of new disease in this group of patients.

Conditions

  • Foot Ulceration in Diabetes

Interventions

OTHER

Education

Patients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes.

Sponsors & Collaborators

  • Diabetes UK

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • William J Jeffcoate · Nottingham University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2006-04-30
Completion
2006-12-31

Countries

  • United Kingdom

Study Locations

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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 NCT00729456 on ClinicalTrials.gov