| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN40423820 |
| Date ISRCTN assigned | 22/05/2007 |
| Local reference number(s) | Protocol Version 1.3 (19/12/2006) |
| Public title | Comparison of insoles prescribed for diabetic patients with and without pedobarograph data |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Diabetes type one and two |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Approval received from the North Nottinghamshire Local Research Ethics Committee on the 5th April 2007 (ref: 06/Q2402/72). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
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| Anticipated start date | 01/01/2007 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Target number of participants | 402 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | To evaluate how neuropathy, ischaemia and deformity affect the outcome of using an insole. |
| Sources of funding | Derby Hospitals NHS Foundation Trust (UK) - Grant Scheme |
| Sponsor name | Derby Hospitals NHS Foundation Trust (UK) |
| Sponsor details | Research and Development Office
Medical School
Derby City General Hospital
Uttoxeter Road
Derby
United Kingdom
DE22 3NE |
| Sponsor website | http://www.derbyhospitals.nhs.uk/ |
| Contact name | Mr Steve Attfield |
| Contact details | Gait and Movement Laboratory
Derbyshire Royal Infirmary
London Road
Derby
United Kingdom
DE1 2QY |
| Contact telephone | +44 (0)1332 254 793 |
| Contact email | steve.attfield@derbyhospitals.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN40423820 |
| Date last extracted from ISRCTN register | 17/04/2008 |
