| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN80835416 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0050058361 |
| Public title | A comparative study of the therapeutic effects of continuous and pulsed laser light on wound healing rates. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Injury, Occupational Diseases, Poisoning: Wound healing |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Not provided at time of registration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 06/07/1999 |
| Anticipated end date | 31/07/2003 |
| Status of trial | Completed |
| Target number of participants | 80 minimum in four groups each of 20 subjects |
| Interventions | The study will be double-blinded. 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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Bradford Teaching Hospitals NHS Foundation Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Peter Vowden |
| Contact details | Department of Vascular Surgery
Bradford Royal Infirmary
Duckworth Lane
Bradford
United Kingdom
BD9 6RJ |
| Contact telephone | +44 (0)1274 364466 |
| Contact fax | +44 (0)1274 364807 |
| Contact email | peter.vowden@bradfordhospitals.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN80835416 |
| Date last extracted from ISRCTN register | 17/04/2008 |
