Do stretching exercises reduce plantar pressure in the at-risk diabetic foot?

ISRCTN	ISRCTN46861855
DOI	https://doi.org/10.1186/ISRCTN46861855
Secondary identifying numbers	N0203121474

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

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

Ms Sue Pyle
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5BW
United Kingdom

Phone	+44 (0)1392 402204
Email	hf@cct.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	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. Study endpoints: To assess if this treatment (compared to no treatment): 1. Increases the range of movement at the ankle joint 2. Reduces peak plantar pressure
Secondary outcome measures	Not provided at time of registration
Overall study start date	27/01/2003
Completion date	31/10/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5BW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Royal Devon and Exeter NHS Trust (UK)

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

03/01/2020: No publications found, all search options exhausted, study status unverified.