Randomised controlled trial of the effectiveness of low level laser therapy given by District Nurses in the treatment of chronic wounds and ulcers on the lower leg
| ISRCTN | ISRCTN21741608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21741608 |
| Secondary identifying numbers | N0670159738 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 07/04/2014
- 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
Mrs Christine Parr
Scientific
Scientific
St Swithun's House
North Allington
Bridport
DT6 5DX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Laser therapy in chronic wound management |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2004 |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Sample size 135. Stratified randomisation for patients with diabetes or rheumatoid arthritis. |
| Key inclusion criteria | 1. Age > 18 2. Lower leg wound or ulcer for > 6 weeks not responding to conventional treatment. |
| Key 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 |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Swithun's House
Bridport
DT6 5DX
United Kingdom
DT6 5DX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Wessex Primary Care Research Network RM&G Unit, South West Dorset PCT (UK)
No information available
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 |
