Do stretching exercises reduce plantar pressure in the at-risk diabetic foot?
| ISRCTN | ISRCTN46861855 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46861855 |
| Protocol serial number | N0203121474 |
| Sponsor | Department of Health (UK) |
| Funder | Royal Devon and Exeter NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 03/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5BW
United Kingdom
| Phone | +44 (0)1392 402204 |
|---|---|
| hf@cct.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | - |
| Study objectives | As limited joint movement does not affect the joints directly but rather the soft tissues surrounding them, we hypothesise that mobilisation techniques may prevent some of the destructive, pathomechanical forces initiated by joint limitation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetes |
| Intervention | A pilot pragmatic, randomised control trial will be undertaken to assess the effect of teaching stretching exercises to patients with limited joint movement. The primary outcomes will be the improvement in the range of movement and a reduction in the peak plantar pressure. Measurement of range of movement and plantar pressure will be taken monthly; 50% of recruits will be required to follow a set exercise programme twice weekly, for a total of 12 weeks. Patients will be contacted fortnightly to monitor progress. |
| Intervention type | Other |
| Primary outcome measure(s) |
This is a pilot study that aims to provide preliminary data to test the hypothesis that regular stretching exercises of the foot and ankle will reduce the risk of ulceration in diabetic, neuropathic feet by improving the range of movement of the ankle and hence lower peak plantar pressures. We will evaluate using a randomised control study of a home treatment plan where diabetic patients with neuropathy and limited joint mobility are taught to use regular stretching exercises. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Diabetic subjects attending the Diabetes and Vascular Centre and local chiropody clinics will be considered for the trial 2. Over 35 years of age 3. Diabetes mellitus 4. Peripheral sensory neuropathy |
| Key exclusion criteria | 1. Arthritic conditions (e.g., osteo/rheumatoid) 2. Partial amputation 3. Previous severe trauma (fracture/tendon rupture/charcots) 4. Excessive scar tissue 5. Surgical intervention 6. Severe gait disturbance 7. Peripheral vascular disease (PVD) 8. Known collagen disorders |
| Date of first enrolment | 27/01/2003 |
| Date of final enrolment | 31/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
EX2 5BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
03/01/2020: No publications found, all search options exhausted, study status unverified.
