| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN71578179 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0013154714 |
| Public title | Ultrasonic assisted debridement in venous leg ulcer. A randomised controlled trial. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cardiovascular: Venous ulcers |
| Study hypothesis | Utilizing ultrasound to debride chronic leg ulcer. Will this improve chronic leg ulcer healing and avoid a possible painful sharp debridement? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 200 patients who suffer from venous leg ulcer will be recruited from the ulcer clinic. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/05/2004 |
| Anticipated end date | 01/05/2005 |
| Status of trial | Completed |
| Target number of participants | 200 |
| Interventions | 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.
|
| Primary outcome measure(s) | Ulcer sizes, complete or incomplete healing. |
| Secondary outcome measure(s) | See Primary outcome measures |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Kevin Burnand |
| Contact details | Guy's and St Thomas' NHS Foundation Trust
General, Vascular and Colorectal Surgery Department
F01 North Wing
St Thomas' Hospital, Lambeth Palace Road
London
United Kingdom
SE1 7EH |
| Contact telephone | +44 (0)20 7188 2570 |
| Contact fax | +44 |
| Contact email | Kevin.burnand@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71578179 |
| Date last extracted from ISRCTN register | 17/04/2008 |
