Community Treatment of Venous Ulcers with Concomitant Use of Compression Pump and V.A.C. Suction Therapy - A Novel Approach

ISRCTN	ISRCTN67751142
DOI	https://doi.org/10.1186/ISRCTN67751142
Protocol serial number	N0388170252
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Hillingdon Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr S Das
Scientific

The Hillingdon Hospital NHS Trust
The Hillingdon Hospital
Pield Health Road
Uxbridge
UB8 3NN
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Community Treatment of Venous Ulcers with Concomitant Use of Compression Pump and V.A.C. Suction Therapy - A Novel Approach
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Venous ulcers
Intervention	Compression pump and suction therapy versus standard 4 layer bandages
Intervention type	Other
Primary outcome measure(s)	Complete healing of venous ulcers
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	05/03/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key inclusion criteria	1. Patients with chronic venous ulcer with an area of >25 sq cm 2. Aged between 18 and 80 years old
Key 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
Date of first enrolment	02/02/2005
Date of final enrolment	05/03/2007

The Hillingdon Hospital NHS Trust

Uxbridge
UB8 3NN
United Kingdom

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