Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/04/2015
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

Dr E Van Ross

ORCID ID

Contact details

Disablement Services Centre
South Manchester University Hospitals NHS Trust
Withington Hospital
Nell Lane
Manchester
M20 2LR
United Kingdom
+44 (0)161 613 7257
Ernest.Vanross@smuht.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226114890

Study information

Scientific title

The effectiveness of manipulation therapy on joint mobility in the diabetic foot

Acronym

Study hypothesis

To investigate the effectiveness of manipulation therapy in improving joint mobility in the diabetic foot; to determine the range of motion at the first metatarso-phalangeal joint and ankle joint before and after manipulation therapy; to determine plantar foot pressures before and after manipulation therapy.

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 and endocrine diseases: Diabetic foot ulcer

Intervention

Patients randomised to both the study and control groups will have the range of motion at the 1st metatarso-phalangeal and ankle joint measured.
The study group will then have the manipulation therapy.
In the control group, patients will have joint mobility and foot pressure measurements at 6 weeks apart, with option for manipulation therapy after completion of the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in joint mobility at first metatarso-phalangeal and ankle joint after manipulation treatment.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

12 patients (attending the MFH, MDC, DSC and community podiatry clinics) with a positive prayer sign, neuropathy disability score of >6, presence of at least one foot pulse.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

12

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2003

Recruitment end date

01/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Manchester University Hospitals NHS Trust
Manchester
M20 2LR
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

South Manchester University Hospitals 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