Evaluating a novel semi-rigid casted slipper in diabetic ischaemic foot ulcers
| ISRCTN | ISRCTN96887379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96887379 |
| Secondary identifying numbers | N0155184582 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 15/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Prof P G Wiles
Scientific
Scientific
Department of General Medicine
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Ulcer size and patient-focused outcomes |
| Secondary outcome measures | Patient satisfaction and quality of life |
| Overall study start date | 01/10/2006 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of General Medicine
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Pennine Acute Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
