Condition category
Circulatory System
Date applied
06/06/2005
Date assigned
09/06/2005
Last edited
21/07/2011
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.venus3.co.uk

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Andrea Nelson

ORCID ID

Contact details

School of Healthcare
Baines Wing
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 3431373
E.A.Nelson@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 02/37/03

Study information

Scientific title

Acronym

VenUS III

Study hypothesis

Low dose ultrasound will accelerate the healing of 'hard to heal' venous leg ulcers used in addition to compression bandaging

Ethics approval

Added 21 August 2008: Favourable ethics review provided by York Research Ethics Committee (UK) on 04/02/2005 (Ref 05/Q1108/3).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Venous ulcers

Intervention

Low dose ultrasound administered weekly for 12 weeks, for between 5 and 10 minutes using in conjunction with compression therapy versus compression therapy alone.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to complete healing of all ulcers.

Secondary outcome measures

1. Proportion of patients with all ulcers healed at 24 weeks
2. Costs of healing ulcers
3. Health related quality of life
4. 12 month recurrence rate

Overall trial start date

01/05/2005

Overall trial end date

30/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

People with venous ulcers treated in community or hospital out-patients with venous ulcers defined as hard to heal based on their being larger than 5 cm^2 or of greater than 6 months duration (or both).
Able and willing to give informed written consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

336

Participant exclusion criteria

Active infection in the ulcer, presence of shrapnel or joint replacements near ulcerated area; allergy to ultrasound transmission gel.

Recruitment start date

01/05/2005

Recruitment end date

30/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Healthcare
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

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. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16669305
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21385806
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21375959
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21432578

Publication citations

  1. Results

    Watson JM, Kang'ombe AR, Soares MO, Chuang LH, Worthy G, Bland JM, Iglesias C, Cullum N, Torgerson D, Nelson EA, , Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial., BMJ, 2011, 342, d1092.

  2. Results

    Watson JM, Kang'ombe AR, Soares MO, Chuang LH, Worthy G, Bland JM, Iglesias C, Cullum N, Torgerson D, Nelson EA, , VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers., Health Technol Assess, 2011, 15, 13, 1-192, doi: 10.3310/hta15130.

  3. Results

    Jans T, Philipsen A, Graf E, Ihorst G, Gerlach M, Warnke A, Does the treatment of maternal attention deficit and hyperactivity disorder (ADHD) enhance the efficacy of a behavioural parent training for the treatment of their children's ADHD? Study protocol of a randomized controlled multicentre trail., Atten Defic Hyperact Disord, 2009, 1, 1, 33-45, doi: 10.1007/s12402-009-0004-4.

  4. Watson J, Nelson EA, An exploration of the use of ultrasound in the treatment of chronic venous leg ulcers., J Wound Care, 2006, 15, 1, 39-41.

Additional files

Editorial Notes