Evaluation of Education in the Secondary Prevention of Foot Ulceration in Diabetes (ESP)

August 4, 2008 updated by: Nottingham University Hospitals NHS Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a randomised controlled trial of the effect over 12 months of a one-to-one educational package designed to improve foot care behaviour in a group of patients at the highest risk of new foot disease: those with a recently healed ulcer. The primary outcome was the incidence of new ulceration at 12 months. Secondary outcomes included self-reported footcare behaviour, new ulceration at 6 months, amputation (major or minor) at 12 and 6 months, and measures of well-being (SF36; Diabetic Foot Ulcer Scale, DFS short-form). The educational intervention was based on the content of the International Consensus on the Diabetic Foot, 2003, was modified following discussion with a focus group of former ulcer sufferers, and included graphic images of different forms of foot disease. Although structured, the information was targeted in discussion to the individual's circumstances, and was delivered one-to-one in the patient's own home by a single health care professional. It was reinforced after one month by a semi-structured phone conversation with the same educator. Outcomes were determined by postal questionnaire, backed up with reminders and phone calls when necessary, as well questionnaires sent to GP staff and by searching hospital records. Foot care behaviour was assessed at 12 months using a newly devised and validated measure of footcare function (NAFF) which was also delivered by post. All outcomes were assessed by researchers blind to allocation group. Mean age was 64.9 (SD 10.9) years, and there were no differences between groups at baseline in terms of demographics, diabetes type and complications. The incidence (%) of new ulcers at 6 and 12 months was 26 (30%) and 36 (41%) in the intervention group and 18 (21%) and 35 (41%) in the controls, RR 0.997 (CI 0.776-1.280). There were no differences in any of the other outcome measures although the intervention group reported a higher score in recommended foot care behaviour when compared with controls (42.0 versus 38.7, p=0.03).

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Derbyshire, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Queens Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diabetes and an ulcer of the foot which had been managed at one of the three participating centres and which had healed within the preceding 3 months, leaving them ulcer-free for at least 28 days

Exclusion Criteria:

  • Living in institutional care
  • Documented history of dementia
  • Other serious medical problems
  • Non-English speaking and without an English-speaking carer
  • Lived more than 50 miles from the centre
  • Involved in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Other: 2
Patients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ulcer recurrence.
Time Frame: 6 and 12 months
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Amputation. Quality of life. Mood. Well-being. Compliance.
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

Diabetes UK

Investigators

  • Principal Investigator: William J Jeffcoate, Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 4, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02ME06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Foot Ulceration in Diabetes

Clinical Trials on Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe