Comparison of insoles prescribed for diabetic patients with and without pedobarograph data

ISRCTN	ISRCTN40423820
DOI	https://doi.org/10.1186/ISRCTN40423820
Secondary identifying numbers	Protocol Version 1.3 (19/12/2006)

Submission date: 20/12/2006
Registration date: 22/05/2007
Last edited: 15/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Steve Attfield
Scientific

Gait and Movement Laboratory
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Phone	+44 (0)1332 254 793
Email	steve.attfield@derbyhospitals.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Comparison of insoles prescribed for diabetic patients with and without pedobarograph data
Study objectives	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(s)	North Nottinghamshire Local Research Ethics Committee, 05/04/2007, ref: 06/Q2402/72
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	01/01/2007
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	402
Key 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
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Gait and Movement Laboratory

Derby
DE1 2QY
United Kingdom

Sponsor information

Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Office
Medical School
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom

Website	http://www.derbyhospitals.nhs.uk/

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK) - Grant Scheme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/03/2016: No publications found, study status unverified