Randomised controlled trial of the use of three dressing regimens in the management of chronic ulcers of the foot in diabetes.
| ISRCTN | ISRCTN52817488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52817488 |
| Protocol serial number | N0116140783 |
| Sponsor | Department of Health |
| Funders | Kings College Hospital NHS Trust R&D Consortium (UK), NHS R&D support funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 14/03/2014
- 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
Dr ME Edmonds
Scientific
Scientific
Diabetic Foot Clinic
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)20 7346 3223 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. The primary objective is to test whether modern dressings are more clinical effective than traditional dressings in the treatment of diabetes related foot ulcers. The dressings to be compared will be: a simple, traditional non-adherent preparation (N-A), a widely used modern antiseptic preparation (Inadine), and a new hydrofibre preparation of higher unit cost (Aquacel). All three dressings are widely used in clinical practices in the UK. 2. To investigate changes in ulcer size, condition and reoccurrence during the study period associated with each dressing. 3. To determine the cost-effectiveness associated with each of the three dressings. 4. To assess the patients' mood, satisfaction and quality of life associated with each of the three dressings. 5. To investigate the patient and carer contribution to care in terms of involvement with self-care, and to gain qualitative insights into the patient experience with each of the dressing interventions. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetic foot |
| Intervention | The dressings to be compared will be: a simple, traditional non-adherent preparation (N-A), a widely used modern antiseptic preparation (Inadine) and a new hydrofibre preparation of higher unit cost (Aquacel). |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Diabetic Foot Clinic
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
