Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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

Ms Sue Pyle

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5BW
United Kingdom
+44 (0)1392 402204

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203121474

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

27/01/2003

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant 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

Recruitment start date

27/01/2003

Recruitment end date

31/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Royal Devon and Exeter NHS Trust (UK)

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