Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2014
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

Mrs Christine Parr

ORCID ID

Contact details

St Swithun's House
North Allington
Bridport
DT6 5DX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0670159738

Study information

Scientific title

Acronym

Study hypothesis

Laser therapy in chronic wound management

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

Not Specified

Patient information sheet

Condition

Cardiovascular: Leg ulcer

Intervention

Comparison of conventional treatment (bandages and ointments) versus conventional treatment + twice weekly low level laser treatment for 12 weeks.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patients self-assessment of pain and interference with life, change in size or healing of wound or ulcer, number of days on antibiotic treatment

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2004

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 18
2. Lower leg wound or ulcer for > 6 weeks not responding to conventional treatment.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Sample size 135. Stratified randomisation for patients with diabetes or rheumatoid arthritis.

Participant exclusion criteria

1. Pregnant
2. Known or suspected lower leg malignancy
3. Photosensitivity
4. Transplant patient
5. Laser treatment to affected leg in last 6 months

Recruitment start date

01/02/2004

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Swithun's House
Bridport
DT6 5DX
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

Government

Funder name

Wessex Primary Care Research Network RM&G Unit, South West Dorset PCT (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