Ultrasonic assisted debridement in venous leg ulcer: A randomised controlled trial

ISRCTN	ISRCTN71578179
DOI	https://doi.org/10.1186/ISRCTN71578179
Secondary identifying numbers	N0013154714

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 12/08/2016

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

Prof Kevin Burnand
Scientific

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

Phone	+44 20 7188 2570
Email	Kevin.burnand@kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Ultrasonic assisted debridement in venous leg ulcer: A randomised controlled trial
Study objectives	Utilizing ultrasound to debride chronic leg ulcer. Will this improve chronic leg ulcer healing and avoid a possible painful sharp debridement?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Ulcer sizes, complete or incomplete healing.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2004
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key inclusion criteria	200 patients who suffer from venous leg ulcer will be recruited from the ulcer clinic.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/05/2004
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's and St Thomas' NHS Foundation Trust

London
SE1 7EH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Guy's and St Thomas' NHS Foundation Trust
Government organisation / Local government

Location: United Kingdom

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

Editorial Notes

12/08/2016: No publications found in PubMed, verifying study status with principal investigator.