Randomised controlled trial of the use of three dressing regimens in the management of chronic ulcers of the foot in diabetes
| ISRCTN | ISRCTN78366977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78366977 |
| Protocol serial number | HTA 01/74/03 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 11/06/2004
- Registration date
- 14/06/2004
- Last edited
- 10/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr William Jeffcoate
Scientific
Scientific
FUTU
David Evans Research Centre
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
| Phone | +44 (0)115 8405859 |
|---|---|
| wjeffcoate@futu.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration. Plain English Summary can be found at: http://www.hta.ac.uk/1357 Protocol available at: http://www.ncchta.org/protocols/200100740003.pdf The trial is also listed on Nottingham Foot Ulcer Trials Unit website: http://www.futu.co.uk/research01.htm |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Diabetic Foot Ulcers |
| Intervention | Non-adherent (NA), Aquacel and Inadine dressings |
| 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 | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | Patients selected from those attending or newly referred to established expert multidisciplinary clinics for the management of diabetic foot ulcers in Blackburn, Hull, Ipswich, Newport, Nottingham and King's College Hospital, London |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
FUTU
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No |
