Pressure UlcerNCT01500174
Ultraviolet-C Effectiveness in the Management of Pressure Ulcers in People With Spinal Cord Injury
A study testing ultraviolet therapy UV254 in people with Pressure Ulcer, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- ultraviolet therapy UV254
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic, non-traumatic or congenital spinal cord injury C2-L2
- pressure ulcer stage 2 or higher
Who cannot join
- neoplastic wound
- wound surgically repaired within past 3 months
- wound currently treated with negative pressure therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial
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.
Read the detailed description
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.
- Conditions
- Pressure Ulcer
- Being tested
- ultraviolet therapy UV254, Placebo ultraviolet therapy UV254
- Keywords
- skin, decubitus, pressure, sore, spinal cord injury
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultraviolet therapy UV254Device
three times per week until wound closure or patient discharge from hospital
Placebo ultraviolet therapy UV254Device
Three times per week irradiation of wound base and periwound skin
| Study group | Role | What they receive |
|---|---|---|
| active UVC device | Experimental | Three times per week irradiation of wound base and periwound skin Receives: Device: ultraviolet therapy UV254 |
| Placebo UVC device | Placebo comparator | Three times per week irradiation of wound base and periwound skin Receives: Device: Placebo ultraviolet therapy UV254 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 1, 6 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startNov 2007
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, Ethne L Nussbaum, Toronto Rehabilitation Institute
- Investigators
- Ethne L Nussbaum, PhD, Principal investigator, Toronto Rehabilitation InstituteColleen F McGillivray, MD, FRCPC, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500174
- Sponsor's protocol ID
- SCI-2007-BDRST-465
- Status last verified
- Sep 2012
- First submitted
- 14 Dec 2011
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nussbaum EL, Biemann I, Mustard B. Comparison of ultrasound/ultraviolet-C and laser for treatment of pressure ulcers in patients with spinal cord injury. Phys Ther. 1994 Sep;74(9):812-23; discussion 824-5. doi: 10.1093/ptj/74.9.812.
PubMed 8066108Nussbaum EL, Flett H, Hitzig SL, McGillivray C, Leber D, Morris H, Jing F. Ultraviolet-C irradiation in the management of pressure ulcers in people with spinal cord injury: a randomized, placebo-controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):650-9. doi: 10.1016/j.apmr.2012.12.003. Epub 2012 Dec 13.
PubMed 23246896
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01500174
- Acronym / sponsor ID
- SCI-2007-BDRST-465
- Conditions
- Pressure Ulcer
- Keywords
- skin, decubitus, pressure, sore, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Nov 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active UVC device | Experimental | Device: ultraviolet therapy UV254Three times per week irradiation of wound base and periwound skin |
| Placebo UVC device | Placebo comparator | Device: Placebo ultraviolet therapy UV254Three times per week irradiation of wound base and periwound skin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- traumatic, non-traumatic or congenital spinal cord injury C2-L2
- pressure ulcer stage 2 or higher
Key exclusion criteria (3 listed)
- neoplastic wound
- wound surgically repaired within past 3 months
- wound currently treated with negative pressure therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultraviolet therapy UV254three times per week until wound closure or patient discharge from hospital | Device | active UVC device |
| Placebo ultraviolet therapy UV254Three times per week irradiation of wound base and periwound skin | Device | Placebo UVC device |
Primary outcome
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.
4 secondary outcomes
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
Change in Photographic Wound Assessment Tool (PWAT)
Time frame: From baseline to wound closure or when the subject is discharged from hospital
Change in Cardiff Wound Impact Schedule (CWIS)
Time frame: From baseline to wound closure or when subject is discharged from hospital
Follow-up wound status
Time frame: At 1, 6 and 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
- Background: PubMed 8066108Nussbaum EL, Biemann I, Mustard B. Comparison of ultrasound/ultraviolet-C and laser for treatment of pressure ulcers in patients with spinal cord injury. Phys Ther. 1994 Sep;74(9):812-23; discussion 824-5. doi: 10.1093/ptj/74.9.812.
- Derived from this study: PubMed 23246896Nussbaum EL, Flett H, Hitzig SL, McGillivray C, Leber D, Morris H, Jing F. Ultraviolet-C irradiation in the management of pressure ulcers in people with spinal cord injury: a randomized, placebo-controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):650-9. doi: 10.1016/j.apmr.2012.12.003. Epub 2012 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethne L Nussbaum, PhD principal investigator
Toronto Rehabilitation Institute
Colleen F McGillivray, MD, FRCPC principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultraviolet therapy UV254 in people with Pressure Ulcer, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.