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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11073179
Publication citations
-
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.