Hard-to-heal WoundsNCT07520825
Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults
A study testing Photobiomodulation and Standard-of-care ulcer dressing in people with Hard-to-heal Wounds and Venous Leg Ulcer (VLU), run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hard-to-heal Wounds, Venous Leg Ulcer (VLU), Arterial Leg Ulcer
- What is being tested?
- Photobiomodulation and Standard-of-care ulcer dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,290 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
- 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.
Who cannot join
- 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.
- Individual with ulcers not classified as hard-to-heal ulcer.
- Individual with hard-to-heal ulcer not diagnosed with defined aetiology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Photobiomodulation in Addition to Standard-of-care for Hard-to-heal Ulcers in Frail Older Adults With Municipality Home Healthcare
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.
Read the detailed description
The study is a prospective quasi-experimental study with non-randomized matched control groups, from the Swedish RiksSår registry for ulcer treatment. The health economic evaluation will be based on the results from the photobiomodulation treatment (PBM) study, including data extraction from patient records. The healthcare professionals' experiences will be investigated through interviews.
Research questions
- Does PBM treatment reduce the healing time of hard-to-heal ulcer with defined aetiology, compared to standard-of-care treatment in frail older adults?
- Are factors such as sex, age, number of comorbid conditions, ulcer area, ulcer duration, and physical function associated with healing time?
- What is the recurrence rate of hard-to-heal ulcers of respective aetiology at 6, 12, 18, and 24 months after healing with PBM?
- How does patients self-assess pain and ulcer-related restraints during the photobiomodulation treatment period?
- Is PBM treatment of hard-to-heal ulcers cost-effective compared to standard-of-care treatment in frail older adults?
- How does healthcare provider experience treating hard-to-heal ulcers in frail older adults with PBM?
- Being tested
- Photobiomodulation, Standard-of-care ulcer dressing
- Keywords
- home healthcare, older adults, frail, hard-to-heal ulcer, primary care, photobiomodulation
- Medical subject headings
- Varicose Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationProcedure or surgery
Photobiomodulation treatment in addition to standard-of-care ulcer dressings for hard-to-heal ulcer according to aetiology.
- 904 nm Infrared PBM applied to lymphatic area and ulcer area.
- Starting at shoulder/neckline (120 s, dose 7.2 J/cm2 bilateral).
- Local lymphatic area closest to the ulcer (120 s, dose 7.2 J/cm2).
- Intact skin close to the ulcer (30 s per location above, below, each side of the ulcer. Dose 1.8 J/cm2, contact application).
- Ulcer surface irradiated at a distance of 1 cm with projection application (120 s per position, dose 7.2 J per laser diode).
- The 635 nm Red PBM treatment applied to ulcer edges and ulcer surface.
- Starting at ulcer edges (30 s per position and a dose of 2.25 J/cm2) and stepwise moved 1cm covering the total ulcer edge with contact application.
- The ulcer surface was irradiated at a distance of 1 cm with projection application, (120 s per position emitting 9 J from the laser diode)
Standard-of-care ulcer dressingProcedure or surgery
Standard-of-care for hard-to-heal ulcer according to aetiology.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Photobiomodulation group, with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare Receives: Procedure: Photobiomodulation |
| Control group | Active comparator | Control groups from the RiksSår registry, with hard-to-heal ulcer diagnosed with a defined aetiology Receives: Procedure: Standard-of-care ulcer dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time: Time in days from initiation of PBM/(baseline registration) until healing.
Healing defined as intact skin in the previous ulcer area.
Measured: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.
Propotion of healed ulcers compared to other ulcer treatment events.
Ulcers are either healed or censored due to death, amputation, or interrupted treatment.
Measured: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.
Secondary outcomes (1)
Ulcer recurrence after healing with photobiomodulation treatment
Following events extracted from patient records at each time-point: healed ulcer and alive, healed ulcer and deceased within the last 6 months, recurrence of ulcer in the prior ulcer location and alive, recurrence of ulcer in the prior ulcer location and deceased within the last 6 months, amputation due to recurred ulcer within the last 6 months, amputation non ulcer related within the last 6 months, lost to follow up/moved away within the last 6 months.
Measured: Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Sep 2020
- Primary completion30 May 2023
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hard-to-heal WoundsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Luleå University of Technology, Skellefteå Municipality
- Responsible party
- Sponsor
- Investigators
- Åsa Audulv, PhD, Principal investigator, Department of Nursing, Umeå University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520825
- Sponsor's protocol ID
- 2020-02194 & 2024-00844-02
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset generated and analyzed during the current study is not publicly available because participant consent included restrictions on use of the data due to patients' privacy concerns. Limited availability is possible.
Publications
Degerman M, Corneliusson L, Ohman M, Schmitt-Egenolf M, Bertilson BC, Audulv A. Photobiomodulation, Compared to Revascularisation, and Conservative Treatment-What Works for Healing Hard-to-Heal Arterial Leg Ulcers in Older Adults: A Quasi-Experimental Study. Wound Repair Regen. 2025 Nov-Dec;33(6):e70106. doi: 10.1111/wrr.70106.
PubMed 41216935Degerman M, Ohman M, Bertilson BC. Photobiomodulation, as additional treatment to traditional dressing of hard-to-heal venous leg ulcers, in frail elderly with municipality home healthcare. PLoS One. 2022 Sep 15;17(9):e0274023. doi: 10.1371/journal.pone.0274023. eCollection 2022.
PubMed 36107964Degerman M, Bertilson BC, Ohman M, Corneliusson L, Schmitt-Egenolf M, Audulv A. Can Photobiomodulation improve healing of category II-III pressure ulcers in frail older adults? A quasi-experimental 24-month follow-up study. PLoS One. 2026 Oct 28;21(10):e0359780. doi: 10.1371/journal.pone.0359780. eCollection 2026.
PubMed 42949889
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Photobiomodulation in Addition to Standard-of-care for Hard-to-heal Ulcers in Frail Older Adults With Municipality Home Healthcare
- ClinicalTrials.gov ID
- NCT07520825
- Acronym / sponsor ID
- 2020-02194 & 2024-00844-02
- Keywords
- home healthcare, older adults, frail, hard-to-heal ulcer, primary care, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Luleå University of Technology, Skellefteå Municipality
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- 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 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.
Detailed description
The study is a prospective quasi-experimental study with non-randomized matched control groups, from the Swedish RiksSår registry for ulcer treatment. The health economic evaluation will be based on the results from the photobiomodulation treatment (PBM) study, including data extraction from patient records. The healthcare professionals' experiences will be investigated through interviews.
Research questions
- Does PBM treatment reduce the healing time of hard-to-heal ulcer with defined aetiology, compared to standard-of-care treatment in frail older adults?
- Are factors such as sex, age, number of comorbid conditions, ulcer area, ulcer duration, and physical function associated with healing time?
- What is the recurrence rate of hard-to-heal ulcers of respective aetiology at 6, 12, 18, and 24 months after healing with PBM?
- How does patients self-assess pain and ulcer-related restraints during the photobiomodulation treatment period?
- Is PBM treatment of hard-to-heal ulcers cost-effective compared to standard-of-care treatment in frail older adults?
- How does healthcare provider experience treating hard-to-heal ulcers in frail older adults with PBM?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Procedure: PhotobiomodulationPhotobiomodulation group, with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare |
| Control group | Active comparator | Procedure: Standard-of-care ulcer dressingControl groups from the RiksSår registry, with hard-to-heal ulcer diagnosed with a defined aetiology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Individual with hard-to-heal ulcer diagnosed with a defined aetiology, registered in the RiksSår registry.
Key exclusion criteria (6 listed)
- 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.
- Individual with ulcers not classified as hard-to-heal ulcer.
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 |
|---|---|---|
| PhotobiomodulationPhotobiomodulation treatment in addition to standard-of-care ulcer dressings for hard-to-heal ulcer according to aetiology. * 904 nm Infrared PBM applied to lymphatic area and ulcer area. * Starting at shoulder/neckline (120 s, dose 7.2 J/cm2 bilateral). * Local lymphatic area closest to the ulcer (120 s, dose 7.2 J/cm2). * Intact skin close to the ulcer (30 s per location above, below, each side of the ulcer. Dose 1.8 J/cm2, contact application). * Ulcer surface irradiated at a distance of 1 cm with projection application (120 s per position, dose 7.2 J per laser diode). * The 635 nm Red PBM treatment applied to ulcer edges and ulcer surface. * Starting at ulcer edges (30 s per position and a dose of 2.25 J/cm2) and stepwise moved 1cm covering the total ulcer edge with contact application. * The ulcer surface was irradiated at a distance of 1 cm with projection application, (120 s per position emitting 9 J from the laser diode) | Procedure or surgery | Photobiomodulation |
| Standard-of-care ulcer dressingStandard-of-care for hard-to-heal ulcer according to aetiology. | Procedure or surgery | Control group |
Primary outcome
Healing time: Time in days from initiation of PBM/(baseline registration) until healing.
Time frame: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.
Healing defined as intact skin in the previous ulcer area.
Propotion of healed ulcers compared to other ulcer treatment events.
Time frame: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.
Ulcers are either healed or censored due to death, amputation, or interrupted treatment.
1 secondary outcome
Ulcer recurrence after healing with photobiomodulation treatment
Time frame: Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publication: PubMed 41216935Degerman M, Corneliusson L, Ohman M, Schmitt-Egenolf M, Bertilson BC, Audulv A. Photobiomodulation, Compared to Revascularisation, and Conservative Treatment-What Works for Healing Hard-to-Heal Arterial Leg Ulcers in Older Adults: A Quasi-Experimental Study. Wound Repair Regen. 2025 Nov-Dec;33(6):e70106. doi: 10.1111/wrr.70106.
- Results publication: PubMed 36107964Degerman M, Ohman M, Bertilson BC. Photobiomodulation, as additional treatment to traditional dressing of hard-to-heal venous leg ulcers, in frail elderly with municipality home healthcare. PLoS One. 2022 Sep 15;17(9):e0274023. doi: 10.1371/journal.pone.0274023. eCollection 2022.
- Derived from this study: PubMed 42949889Degerman M, Bertilson BC, Ohman M, Corneliusson L, Schmitt-Egenolf M, Audulv A. Can Photobiomodulation improve healing of category II-III pressure ulcers in frail older adults? A quasi-experimental 24-month follow-up study. PLoS One. 2026 Oct 28;21(10):e0359780. doi: 10.1371/journal.pone.0359780. eCollection 2026.
- Project webpage in Swedish: Kan medicinsk laser (laser photobiomodulation, PBM) stödja läkning av svårläkta sår hos sköra äldre i kommunal hälso- och sjukvård?Link provided by the sponsor.
- Individual participant dataSharing planned: No. The dataset generated and analyzed during the current study is not publicly available because participant consent included restrictions on use of the data due to patients' privacy concerns. Limited availability is possible.
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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.
Åsa Audulv, PhD principal investigator
Department of Nursing, Umeå University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and Standard-of-care ulcer dressing in people with Hard-to-heal Wounds and Venous Leg Ulcer (VLU), run by Umeå University at 1 site in Sweden.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. 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 Sweden. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Healing time: Time in days from initiation of PBM/(baseline registration) until healing. (time frame: From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.). The study lists 2 primary outcomes in all. 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 NCT07520825, which also lists 3 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 9 Apr 2026.