The clinical and cost effectiveness of footwear and orthotic therapy in the management of the neuropathic diabetic foot - a single blind randomised controlled trial
| ISRCTN | ISRCTN87231372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87231372 |
| Secondary identifying numbers | N0184175869 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 29/03/2012
- 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
Mrs Joanne Paton
Scientific
Scientific
FF21 Peninsula Allied Health Centre
University of Plymouth
Derriford Road
Plymouth
PL6 9BH
United Kingdom
| Phone | +44 1752 238845 |
|---|---|
| joanne.paton@plymouth.ac.uk |
Study information
| Study design | Single blind randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | To determine whether therapeutic shoes used with 2 types of inserts reduce peak pressure in the at-risk diabetic foot, and to determine which of the orthotics is most effective. |
| Ethics approval(s) | Added 29 July 2008: Ethical approval was granted by Cornwall and Plymouth Research Ethics Committee on 24/01/2006, prior to the commencement of recruitment. |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetes |
| Intervention | The participants will be taken from both referrals and the existing caseload of the North and East Cornwall PCT Podiatry Service and Plymouth PCT podiatry service. Each participant will be required to complete a questionnaire and sign a consent form before taking part in the study. Each participant will receive a diabetic assessment of the lower limb to determine if they present with an increased risk of foot ulceration. Identification of the increased-risk foot include a neurological foot assessment. Each participant will be randomly assigned to one of two groups: Group 1 will receive 2 pairs of orthopaedic shoes and a custom made moulded insert Group 2 will receive 2 pairs of orthopaedic shoes and inlay |
| Intervention type | Other |
| Primary outcome measure | Plantar peak pressure for the entire plantar surface during the stance phase of gait. |
| Secondary outcome measures | Added 29 July 2008: 1. Forefoot pressure time integral 2. Total contact area 3. Rate of forefoot loading 4. Duration of load as a percentage of stance 5. Perceived foot health 6. Quality of life 7. Cost |
| Overall study start date | 03/03/2006 |
| Completion date | 02/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Sample size estimate n=130. 65 participants in each group. |
| Key inclusion criteria | 1. The subject must be diagnosed as type I or II diabetic 2. The subject must be identified as neuropathic and at risk of ulceration 3. The subject must not currently be suffering from any lower limb vascular or neuropathic ulceration identified by scoring Grade 0 on the Wagner classification for foot ulcer 4. The subject must be ambulant. Must be able to walk a minimum of approximately 10 metres unaided 5. The subject must be willing to comply with the requirements of the study |
| Key exclusion criteria | 1. Subjects with current ulceration or recently healed less than 6 months prior to enrolling onto the study (as the focus of the study is preventative ulcer management rather than treatment) 2. Subjects with severe fixed midfoot or rearfoot deformity ie Charcot joint (subjects would be unsuitable for prefabricated insoles and non-bespoke footwear) 3. Subjects with a history of bone and joint surgery of the lower limb including amputation (could lead to alteration in gait kinetics and may not be suitable for non bespoke insoles and footwear) 4. Subjects lacking the ability to comprehend simple instructions and comply with the study protocols and procedures (including those not able to read printed English) 5. Allied Health Professional students as they may be considered to have a dependant relationship with the investigator 6. Subjects diagnosed as neuropathic caused by pathology other than diabetes |
| Date of first enrolment | 03/03/2006 |
| Date of final enrolment | 02/03/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
FF21 Peninsula Allied Health Centre
Plymouth
PL6 9BH
United Kingdom
PL6 9BH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Plymouth Primary Care Trust - Exeter PCT (UK) NHS R&D Support Funding
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | systematic review | 01/01/2011 | Yes | No |
