Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0155184582
Study information
Scientific title
Acronym
Study hypothesis
Is the application of semi-rigid coated slippers using soft cast materials, safe and effective in healing ulcers in vulnerable, at risk, ischaemic feet in people with diabetes?
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetic foot
Intervention
Slipper vs standard treatment
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Ulcer size and patient-focused outcomes
Secondary outcome measures
Patient satisfaction and quality of life
Overall trial start date
01/10/2006
Overall trial end date
01/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with diabetic ischaemic foot
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Medicine
Manchester
M8 5RB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Pennine Acute 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