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 | 
| Secondary identifying numbers | N0388170252 | 
- Submission date
 - 29/09/2006
 - Registration date
 - 29/09/2006
 - Last edited
 - 21/04/2015
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Circulatory System
 
            
            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
Contact information
                                            Mr S Das
Scientific
                                        Scientific
                                                The Hillingdon Hospital NHS Trust
The Hillingdon Hospital
Pield Health Road
Uxbridge
UB8 3NN
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Not specified | 
| Study type | Treatment | 
| 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 | Complete healing of venous ulcers | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 02/02/2005 | 
| Completion date | 05/03/2007 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Adult | 
| Lower age limit | 18 Years | 
| Sex | All | 
| Target number of participants | Not provided at time of registration | 
| 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 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            The Hillingdon Hospital NHS Trust
                                        
                                        
                                            
                                            Uxbridge
UB8 3NN
United Kingdom
                                    UB8 3NN
United Kingdom
Sponsor information
                                            Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
                                        Government
                                                The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
                                                
| Phone | +44 (0)20 7307 2622 | 
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en | 
Funders
Funder type
Government
                                                Hillingdon Hospital NHS Trust (UK)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan |