Contact information
Type
Scientific
Primary contact
Prof Kevin Burnand
ORCID ID
Contact details
Guy's and St Thomas' NHS Foundation Trust
General
Vascular and Colorectal Surgery Department
F01 North Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 20 7188 2570
Kevin.burnand@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013154714
Study information
Scientific title
Ultrasonic assisted debridement in venous leg ulcer: A randomised controlled trial
Acronym
Study hypothesis
Utilizing ultrasound to debride chronic leg ulcer. Will this improve chronic leg ulcer healing and avoid a possible painful sharp debridement?
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Venous ulcers
Intervention
This is a randomised controlled trial comparing conventional compression bandage regime alone and with the addition of a maximum of 3 sessions of ultrasonic treatment before applying the compression bandages. Suitable patients will be recruited and matched to a control. Assessment will be taken a different interval up to one year to detect any difference.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Ulcer sizes, complete or incomplete healing.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2004
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
200 patients who suffer from venous leg ulcer will be recruited from the ulcer clinic.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/05/2004
Recruitment end date
01/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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
Hospital/treatment centre
Funder name
Guy's and St Thomas' NHS Foundation Trust
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
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