Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2006
Date assigned
22/05/2007
Last edited
15/03/2016
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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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