Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers
| ISRCTN | ISRCTN76288165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76288165 |
| Protocol serial number | N0295122854 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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 Joanne Deacon
Scientific
Scientific
Department of Dermatology
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers |
| Study objectives | Does topical morphine reduce the systematic requirement for analgesia in the treatment of pain from chronic leg ulcers? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | Prospective randomised controlled cross-over trial with questionnaire and interviews. Topical opioids versus placebo. |
| Intervention type | Other |
| Primary outcome measure(s) |
PRN (pro re nata - as needed) and regular analgesia requirement over preceding 24 h. Daily pain score and questionnaire regarding side-effects. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 Patients with chronic painful leg ulcers, from all inpatients at the Walsgrave Hospital (powered to give 75-80% preference rate of either active or placebo gel). |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Dermatology
Coventry
CV2 2DX
United Kingdom
CV2 2DX
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
