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
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