Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0388170252
Study information
Scientific title
Community Treatment of Venous Ulcers with Concomitant Use of Compression Pump and V.A.C. Suction Therapy - A Novel Approach
Acronym
Study hypothesis
Does the use of compression pump and suction therapy provide better management for venous ulcers than the standard 4 layer bandages being used?
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
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Venous ulcers
Intervention
Compression pump and suction therapy versus standard 4 layer bandages
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Complete healing of venous ulcers
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/02/2005
Overall trial end date
05/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with chronic venous ulcer with an area of >25 sq cm
2. Aged between 18 and 80 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients <18 years of age and >80 years of age
2. Patients likely to be pregnant
3. Patients who are immobile
4. Patients with peripheral vascular disease with ankle brachial pressure index (ABPI) <0.6 non-diabetics, <0.8 diabetics
5. Patients with recent deep vein thrombosis (DVT), congestive cardiac failure or disabling stroke
6. patients with concurrent terminal disease with an expected lifespan <1 year
Recruitment start date
02/02/2005
Recruitment end date
05/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Hillingdon Hospital NHS Trust
Uxbridge
UB8 3NN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hillingdon Hospital NHS Trust (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