Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Tooke

ORCID ID

Contact details

Royal Devon and Exeter Healthcare NHS Trust
Barrack Road
Exeter
EX2 5AW
United Kingdom
+44 (0)1392 403064

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D/05/11.96/Tooke

Study information

Scientific title

Acronym

Study hypothesis

Diabetic foot ulceration and lower limb amputation remain major health problems and the government is committed to the reduction of amputation rates by 50%. Centralised, hospital based specialist foot services have demonstrated that it is possible to reduce amputation rate through patient education and expert medical and chiropodial care. However increasingly routine diabetic care is devolved to general practice and if foot health in the majority of people with diabetes is to be improved care arrangements need to reflect this shift. We propose to evaluate a new model of diabetic foot care, centred on the general practice based diabetic annual review. Five practices will be randomised to receive the new model of care, and associated educational input, with five matched practices continuing with current care arrangements. The success or otherwise of the initiative will be-determined by assessing
1. Patients' understanding of footcare and their attitudes to the footcare service;
2. The knowledge base of the healthcare professionals involved in diabetic footcare, and
3. The appropriateness of patients referred to subserving chiropody units and the specialist foot clinic.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Diabetes

Intervention

A practice visit by the specialist diabetic footcare team to deliver an educational programme; provision of, and instruction in the use of, an objective means of neuropathy assessment (Semmes-Weinstein monofilament); provision of referral guidelines and patient educational material.
Control: current standard care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patients' attitudes regarding the value and importance of footcare
2. Patients' footcare knowledge
3. Healthcare professionals' footcare knowledge
4. Pattern of service utilisation

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1997

Overall trial end date

31/12/1998

Reason abandoned

Eligibility

Participant inclusion criteria

One thousand nine hundred and thirty nine people with diabetes aged over 18 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,939 (cluster randomised practices from 10 towns)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/05/1997

Recruitment end date

31/12/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon and Exeter Healthcare NHS Trust
Exeter
EX2 5AW
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11073179

Publication citations

  1. Results

    Donohoe ME, Fletton JA, Hook A, Powell R, Robinson I, Stead JW, Sweeney K, Taylor R, Tooke JE, Improving foot care for people with diabetes mellitus--a randomized controlled trial of an integrated care approach., Diabet. Med., 2000, 17, 8, 581-587.

Additional files

Editorial Notes