Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes