NCT00729456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
Last Updated

August 7, 2008

Status Verified

July 1, 2008

Enrollment Period

3 years

First QC Date

August 4, 2008

Last Update Submit

August 4, 2008

Conditions

Foot Ulceration in Diabetes

Keywords

DiabetesEducationUlcerFootBehaviour

Outcome Measures

Primary Outcomes (1)

  • Ulcer recurrence.

    6 and 12 months

Secondary Outcomes (1)

  • Amputation. Quality of life. Mood. Well-being. Compliance.

    6 and 12 months

Study Arms (2)

1

NO INTERVENTION

2

OTHER

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

Interventions

EducationOTHER

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Derbyshire Royal Infirmary

Derbyshire, DE1 2QY, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • Lincoln NB, Radford KA, Game FL, Jeffcoate WJ. Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Diabetologia. 2008 Nov;51(11):1954-61. doi: 10.1007/s00125-008-1110-0. Epub 2008 Aug 30.

    PMID: 18758747DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusUlcerBehavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • William J Jeffcoate

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

April 1, 2003

Primary Completion

April 1, 2006

Study Completion

December 1, 2006

Last Updated

August 7, 2008

Record last verified: 2008-07

Locations

GB(3)