Contact information
Type
Scientific
Primary contact
Mr Steve Attfield
ORCID ID
Contact details
Gait and Movement Laboratory
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 254 793
steve.attfield@derbyhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol Version 1.3 (19/12/2006)
Study information
Scientific title
Comparison of insoles prescribed for diabetic patients with and without pedobarograph data
Acronym
Study hypothesis
Participants who have custom made insoles based on a pedobarograph assessment will have a reduced incidence of plantar ulceration over a two year period.
Ethics approval
North Nottinghamshire Local Research Ethics Committee, 05/04/2007, ref: 06/Q2402/72
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Diabetes
Intervention
Currently patients are issued with a poron insole designed according to the clinical examination of the foot. Patients who fit the inclusion criteria will be given information regarding the study at their initial appointment and will be asked to consent to be involved. They will receive a baseline assessment, which will include a photograph being taken of the plantar aspect of the feet. This photograph will be taken before debriding the callus. They will then be randomly placed into one of two groups:
Group A: will undergo a pedobarograph assessment and will receive a custom-made poron insole
Group B: will receive an insole assessed following current clinical practice.
Information will also be collected about whether the participant has neuropathy, ischaemia or deformity. If a participant develops a callus that involves a change of insole or an ulcer at any point in the two years, then they would have met the failure criteria of the project. Participants will be instructed at the start of the study to return to podiatry if they develop a callus (or other foot problems). The date of the callus or ulceration causing change of insole design being identified by podiatry will be recorded and used in the study. If the participant is withdrawn from the study for other reasons these will be recorded.
Participants will attend an annual review and at this time if there is no callus or ulceration requiring a change of insole design a new insole of the same design will be issued. A final review of participants remaining in the study will be performed after two years. At any follow up appointments the digital photograph from the initial assessment will be used as a reference to identify changes in the plantar surface of the foot.
Data will be collected from both groups of participants over two years and following this the average time to callus/ulceration in the two groups will be analysed. There will also be an analysis of specific groups of patients, e.g., those with neuropathy, show a more significant difference between the two groups. The reasons for participants being withdrawn from the study will also be analysed. The patients will all be recruited in the first year and then followed up over two years from their entry date into the study. Kaplien-Meier survival curves will be plotted for the two groups.
Intervention type
Device
Phase
Drug names
Primary outcome measure
To evaluate whether custom made insoles for diabetic patients which are guided in design by the pedobarograph data are more effective in reducing skin damage/callus/ulceration than those assessed via current clinical practice.
Secondary outcome measures
To evaluate how neuropathy, ischaemia and deformity affect the outcome of using an insole.
Overall trial start date
01/01/2007
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Able to walk a minimum of five metres unaided
2. New referral to podiatry
3. Presenting with plantar callus at initial podiatry assessment
4. No previous insole treatment
5. Aged greater than 18 years old
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
402
Participant exclusion criteria
1. Unable to walk a minimum of five metres unaided
2. Current ulceration
3. Previous insole treatment
4. Non-diabetes related medical problems affecting the lower limbs
5. Lower limb amputation at any level
6. Unclear diabetes diagnosis
7. Congenital foot deformities
8. Charcot foot changes
9. Previous foot or ankle surgery
Recruitment start date
01/01/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gait and Movement Laboratory
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Derby Hospitals NHS Foundation Trust (UK)
Sponsor details
Research and Development Office
Medical School
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK) - Grant Scheme
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