Ultrasonic assisted debridement in venous leg ulcer: A randomised controlled trial
| ISRCTN | ISRCTN71578179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71578179 |
| Protocol serial number | N0013154714 |
| Sponsor | Department of Health |
| Funder | Guy's and St Thomas' NHS Foundation Trust |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 Kevin Burnand
Scientific
Scientific
Guy's and St Thomas' NHS Foundation Trust
General, Vascular and Colorectal Surgery Department
F01 North Wing
St Thomas' Hospital, Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 20 7188 2570 |
|---|---|
| Kevin.burnand@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Ultrasonic assisted debridement in venous leg ulcer: A randomised controlled trial |
| Study objectives | Utilizing ultrasound to debride chronic leg ulcer. Will this improve chronic leg ulcer healing and avoid a possible painful sharp debridement? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Venous ulcers |
| Intervention | This is a randomised controlled trial comparing conventional compression bandage regime alone and with the addition of a maximum of 3 sessions of ultrasonic treatment before applying the compression bandages. Suitable patients will be recruited and matched to a control. Assessment will be taken a different interval up to one year to detect any difference. |
| Intervention type | Other |
| Primary outcome measure(s) |
Ulcer sizes, complete or incomplete healing. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 patients who suffer from venous leg ulcer will be recruited from the ulcer clinic. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom
SE1 7EH
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 |
Editorial Notes
12/08/2016: No publications found in PubMed, verifying study status with principal investigator.
