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Completed

NCT Number: NCT01500174

Ultraviolet-C Effectiveness in the Management of Pressure Ulcers in People With Spinal Cord Injury

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.

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Key information

Conditions

Pressure Ulcer Central Nervous System Diseases Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • traumatic, non-traumatic or congenital spinal cord injury C2-L2
  • pressure ulcer stage 2 or higher

Exclusion criteria

  • neoplastic wound
  • wound surgically repaired within past 3 months
  • wound currently treated with negative pressure therapy

Treatment and study plan

ultraviolet therapy UV254

Device

three times per week until wound closure or patient discharge from hospital

Placebo ultraviolet therapy UV254

Device

Three times per week irradiation of wound base and periwound skin

Primary outcomes

  1. Change in ulcer area 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

    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.

Secondary outcomes

  1. Mean change in ulcer area between consecutive weeks

    Time frame: At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 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.

  2. Change in Photographic Wound Assessment Tool (PWAT)

    Time frame: From baseline to wound closure or when the subject is discharged from hospital

    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.

  3. Change in Cardiff Wound Impact Schedule (CWIS)

    Time frame: From baseline to wound closure or when subject is discharged from hospital

    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.

  4. Follow-up wound status

    Time frame: At 1, 6 and 12 months post-intervention

    Telephone interview - subjects were asked about status of study wounds - open or closed

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Ontario Neurotrauma Foundation

Registry information

Official study title

Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Dec 28, 2011
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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