Contact information
Type
Scientific
Primary contact
Prof Peter Vowden
ORCID ID
Contact details
Department of Vascular Surgery
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364466
peter.vowden@bradfordhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050058361
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Double-blinded 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
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
06/07/1999
Overall trial end date
31/07/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80 minimum in four groups each of 20 subjects
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
06/07/1999
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Vascular Surgery
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Teaching Hospitals NHS Foundation Trust (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
1. 2003 results in Hart GC, Vowden P, Vowden K, Cameron R, Gregson J, Dugdale R, et al. A Comparative Study on the Effects of Continuous and Pulsed Laser Light on Wound Healing Rates. Laser Med Sci. 2003;18(Supl 1):S1-S67
2. 2004 results in Hart GC, Vowden K, Gregson J, Cameron RG, Lovatt A,. A study of the therapeutic effects of continuous and pulsed laser light on wound healing. In Proceedings 2nd World Union of Wound Healing Societies Meeting; 2004; Paris, France