Condition category
Circulatory System
Date applied
18/06/2004
Date assigned
18/06/2004
Last edited
08/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.york.ac.uk/healthsciences/centres/trials/larthe.htm

Contact information

Type

Scientific

Primary contact

Prof Nicky Cullum

ORCID ID

Contact details

Dept of Health Sciences
SRB (Area 2)
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321343
nac2@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/41/04

Study information

Scientific title

Acronym

VenUS II

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.

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.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Venous and mixed aetiology leg ulcers

Intervention

3 armed trial: Larval therapy (loose and bagged) and Purilon hydrogel

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Added 10/07/08:
Time to healing of reference ulcer

Secondary outcome measures

Added 10/07/08:
1. Time to debridement of reference ulcer
2. Health related quality of life
3. Bacterial load (including MRSA)
4. Adverse event data
5. Costs of leg ulcer treatments

Overall trial start date

01/09/2003

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Adults over 18 years old with leg uclers containing slough and/or necrotic tissue

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added 10/07/08: 370 patients

Participant exclusion criteria

Does not comply with inclusion criteria

Recruitment start date

01/09/2003

Recruitment end date

30/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Heslington
York
YO10 5DD
United Kingdom

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19304577
2. 2009 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/19304578
3. 2009 HTA report in http://www.ncbi.nlm.nih.gov/pubmed/19925723

Publication citations

  1. Results

    Dumville JC, Worthy G, Bland JM, Cullum N, Dowson C, Iglesias C, Mitchell JL, Nelson EA, Soares MO, Torgerson DJ, , Larval therapy for leg ulcers (VenUS II): randomised controlled trial., BMJ, 2009, 338, b773.

  2. HTA report

    Dumville JC, Worthy G, Soares MO, Bland JM, Cullum N, Dowson C, Iglesias C, McCaughan D, Mitchell JL, Nelson EA, Torgerson DJ, , VenUS II: a randomised controlled trial of larval therapy in the management of leg ulcers., Health Technol Assess, 2009, 13, 55, 1-182, iii-iv, doi: 10.3310/hta13550.

  3. Soares MO, Iglesias CP, Bland JM, Cullum N, Dumville JC, Nelson EA, Torgerson DJ, Worthy G, , Cost effectiveness analysis of larval therapy for leg ulcers., BMJ, 2009, 338, b825.

Additional files

Editorial Notes