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
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