Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults (NCT07520825) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults
Sweden1,290 participantsStarted 2020-09-01
Plain-language summary
The aim of this quasi-experimental prospective study is to evaluate the effectiveness of photobiomodulation treatment on hard-to-heal ulcers of various diagnosed aetiologies in frail older adults, admitted to municipal home healthcare. The study also include evaluation of cost-effectiveness, and healthcare providers experiences of treating frail older adults hard-to-heal ulcers with photobiomodulation treatment in home healthcare.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Intervention Arm:
* Individual with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare.
* Assessed as eligible by primary care nurse and physician.
* Consent to treatment with photobiomodulation.
* Consent to the research study.
Inclusion Criteria Control Arm:
* Individual with hard-to-heal ulcer diagnosed with a defined aetiology, registered in the RiksSår registry.
* Consented to use registry information in ulcer related research.
Exclusion Criteria Intervention Arm:
* Individual with ulcers not classified as hard-to-heal ulcer.
* Individual with hard-to-heal ulcer not diagnosed with defined aetiology.
* Individual not treated for hard-to-heal ulcer in home healthcare.
* Individual not consenting to research study.
Exclusion Criteria Control Arm:
* Individual with ulcers not classified as hard-to-heal ulcer.
* Individual with hard-to-heal ulcer not diagnosed with defined aetiology.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Healing time: Time in days from initiation of PBM/(baseline registration) until healing.
Timeframe: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.
2
Propotion of healed ulcers compared to other ulcer treatment events.
Timeframe: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.