| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN55114812 |
| Date ISRCTN assigned | 18/06/2004 |
| Local reference number(s) | HTA 01/41/04 |
| Public title | VenUS II: larval therapy Venous Ulcer Study |
| Scientific title |
|
| Acronym | VenUS II |
| Disease/condition/study domain | Venous and mixed aetiology leg ulcers |
| Study hypothesis | Non-healing leg ulcers are common, costly to the NHS and distressing for patients. Many leg ulcers contain slough and necrotic tissue and, whilst removal of these tissues (debridement) is widely thought to contribute to healing, direct evidence is lacking. Larval therapy has been proposed as a quick and effective debridement strategy and is increasingly used in the NHS, mainly by nurses. Larval therapy may achieve debridement more swiftly than modern wound dressings, which promote a moist environment aiding self debridement, and, unlike surgical debridement, larval therapy use is not reliant on highly trained personnel or the fitness of the patient for surgery. A further benefit of larval therapy, namely the removal of wound bacteria and Methicillin-Resistant Staphylococcus Aureas (MRSA) in particular, has been suggested, but robust evidence of this is also required. This study will establish the cost-effectiveness of larval therapy in the healing of venous and mixed arterial/venous leg ulcers; it will also assess the impact of larval therapy on wound microbiology, including MRSA, and the acceptability of the treatment for patients. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Adults over 18 years old with leg uclers containing slough and/or necrotic tissue |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/09/2003 |
| Anticipated end date | 30/04/2008 |
| Status of trial | Ongoing |
| Target number of participants | Not provided at time of registration. |
| Interventions | Please note that, as of 16 January 2008, the anticipated end date of this trial has been updated from 30 June 2007 to 30 April 2008.
Interventions:
3 armed trial: Larval therapy (loose and bagged) and Purilon hydrogel |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Trial website | http://www.york.ac.uk/healthsciences/centres/trials/larthe.htm |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of York (UK) |
| Sponsor details | Heslington
York
United Kingdom
YO10 5DD |
| Sponsor website | http://www.york.ac.uk/ |
| Contact name | Prof Nicky Cullum |
| Contact details | Dept of Health Sciences
SRB (Area 2)
University of York
Heslington
York
United Kingdom
YO10 5DD |
| Contact telephone | +44 (0)1904 321343 |
| Contact fax | +44 (0)1904 321382 |
| Contact email | nac2@york.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55114812 |
| Date last extracted from ISRCTN register | 17/04/2008 |
