Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/08/2016
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

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

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

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

Publication citations

Additional files

Editorial Notes

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