An interventional study of ultraviolet therapy UV254 and Placebo ultraviolet therapy UV254 in Pressure Ulcer, sponsored by Toronto Rehabilitation Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-05.
Sponsored by Toronto Rehabilitation Institute · Not applicable, Interventional, and Treatment
The objective of the study is to examine the effectiveness of Ultraviolet-C (UVC) for healing pressure ulcers in people with spinal cord injury. UVC is a form of radiation similar to sunlight but it is normally absorbed in the earth's atmosphere. Participants will be assigned by chance to receive placebo-UVC or real UVC treatment, in addition to receiving wound care according to best practice guidelines. The hypothesis is that UVC-treated wounds will heal at a faster rate than wounds receiving placebo treatment.
Given that pressure ulcers impact on an individual's quality of life, and generate high costs to the overall health care system, further work is needed to explore alternative means of pressure ulcer treatment.
UVC or placebo UVC will be applied to wounds three times per week. Intact skin around the wound edge and the wound base will be irradiated.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 43 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Toronto Rehabilitation Institute is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Three times per week irradiation of wound base and periwound skin
Device: ultraviolet therapy UV254
Three times per week irradiation of wound base and periwound skin
Device: Placebo ultraviolet therapy UV254
three times per week until wound closure or patient discharge from hospital
Three times per week irradiation of wound base and periwound skin
Change in ulcer area relative to baseline
Wounds are photographed at baseline and measurement is repeated every week either until the wound is closed or the subject is discharged from hospital, up to a maximum of 32 weeks. A metric reference is fixed to skin adjacent to the wound. A blinded assessor measures area directly from the number-coded images using digital software. Percent change is calculated each week relative to baseline.
Time frame: At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks
Mean change in ulcer area between consecutive weeks
Wounds are photographed at baseline and measurement is repeated every week either until the wound is closed or the subject is discharged from hospital, up to a maximum of 32 weeks. A metric reference is fixed to skin adjacent to the wound. A blinded assessor measures area directly from the number-coded images using digital software. Percent change in area relative to the previous measurement is calculated each week for the individual and then averaged for the individual over all weeks of the study.
Time frame: At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks
Change in Photographic Wound Assessment Tool (PWAT)
The PWAT characterizes six aspects of wound appearance (wound edge, necrotic tissue type and amount, skin colour, granulation tissue and epithelialization), and yields scores ranging from 0-24, where higher scores indicate more severe wounds. A blinded assessor scored the PWAT using the number-coded images.
Time frame: From baseline to wound closure or when the subject is discharged from hospital
Change in Cardiff Wound Impact Schedule (CWIS)
The CWIS is a condition-specific quality of life (QOL) tool that evaluates wound impact on four domains: overall QOL, well-being, physical experience and the perceived stress of the physical experience.
Time frame: From baseline to wound closure or when subject is discharged from hospital
Follow-up wound status
Telephone interview - subjects were asked about status of study wounds - open or closed
Time frame: At 1, 6 and 12 months post-intervention
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Toronto Rehabilitation Institute