Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
21/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr S Das

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes