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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesLaser therapy in chronic wound management
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Leg ulcer
InterventionComparison of conventional treatment (bandages and ointments) versus conventional treatment + twice weekly low level laser treatment for 12 weeks.
Intervention typeOther
Primary outcome measurePatients 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 measuresNot provided at time of registration
Overall study start date01/02/2004
Completion date28/02/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsSample size 135. Stratified randomisation for patients with diabetes or rheumatoid arthritis.
Key inclusion criteria1. Age > 18
2. Lower leg wound or ulcer for > 6 weeks not responding to conventional treatment.
Key exclusion criteria1. 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 enrolment01/02/2004
Date of final enrolment28/02/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Swithun's House
Bridport
DT6 5DX
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

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan