Evaluating a novel semi-rigid casted slipper in diabetic ischaemic foot ulcers

ISRCTN	ISRCTN96887379
DOI	https://doi.org/10.1186/ISRCTN96887379
Protocol serial number	N0155184582
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Pennine Acute Hospitals NHS Trust (UK)

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

Prof P G Wiles
Scientific

Department of General Medicine
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Diabetic foot
Intervention	Slipper vs standard treatment
Intervention type	Other
Primary outcome measure(s)	Ulcer size and patient-focused outcomes
Key secondary outcome measure(s)	Patient satisfaction and quality of life
Completion date	01/10/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Patients with diabetic ischaemic foot
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2007

Department of General Medicine

Manchester
M8 5RB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan