VenUS III: Ultrasound for venous leg ulcers

ISRCTN	ISRCTN21175670
DOI	https://doi.org/10.1186/ISRCTN21175670
Protocol serial number	HTA 02/37/03
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Elizabeth Andrea Nelson
Scientific

School of Healthcare
Baines Wing
University of Leeds
Leeds
LS2 9JT
United Kingdom

Phone	+44 (0)113 3431373
Email	E.A.Nelson@leeds.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	VenUS III
Study objectives	Low dose ultrasound will accelerate the healing of 'hard to heal' venous leg ulcers used in addition to compression bandaging
Ethics approval(s)	Added 21 August 2008: Favourable ethics review provided by York Research Ethics Committee (UK) on 04/02/2005 (Ref 05/Q1108/3).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Time to complete healing of all ulcers.
Key secondary outcome measure(s)	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
Completion date	30/10/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	336
Key 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.
Key exclusion criteria	Active infection in the ulcer, presence of shrapnel or joint replacements near ulcerated area; allergy to ultrasound transmission gel.
Date of first enrolment	01/05/2005
Date of final enrolment	30/10/2009

School of Healthcare

Leeds
LS2 9JT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No
Results article	results	01/03/2011		Yes	No
Results article	results	08/03/2011		Yes	No
Protocol article	protocol	01/01/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes