A comparative study of the therapeutic effects of continuous and pulsed laser light on wound healing rates.

ISRCTN	ISRCTN80835416
DOI	https://doi.org/10.1186/ISRCTN80835416
Secondary identifying numbers	N0050058361

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 25/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Vowden
Scientific

Department of Vascular Surgery
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 364466
Email	peter.vowden@bradfordhospitals.nhs.uk

Study information

Study design	Double-blinded 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	The study will investigate whether the effect of pulsed infra-red (IR) laser illumination of wounds can be distinguished from placebo therapy and continuous laser IR illumination and if the responses to pulsed laser therapy correlate with the responses to frequencies used in an earlier study of pulsed electromagnetic fields.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Wound healing
Intervention	80 minimum in four groups each of 20 subjects: A will be the control group, receiving no IR therapy. B will receive IR laser therapy pulsed at 292 Hz. C will receive IR laser therapy pulsed at 700 Hz. D will receive continuous IR laser illumination. Each subject will be assessed on recruitment to the study and given a treatment session twice per week for four weeks. This will be followed by a 4-week observation period ending with the final assessment. After the initial assessment, subjects will be assessed at the ends of weeks 1 - 4 and 8 with a follow-up observation at the end of week 13. Patients' subjective comments will be sought throughout.
Intervention type	Other
Primary outcome measure	The study will test the 'null hypotheses' that there are no significant differences between the control group and any other group at the 95% confidence level.
Secondary outcome measures	Not provided at time of registration
Overall study start date	06/07/1999
Completion date	31/07/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80 minimum in four groups each of 20 subjects
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	06/07/1999
Date of final enrolment	31/07/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Vascular Surgery

Bradford
BD9 6RJ
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

Bradford Teaching Hospitals NHS Foundation Trust (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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		01/09/2003		No	No