Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hard-to-heal Wounds; Venous Leg Ulcer (VLU); Arterial Leg Ulcer; Pressure Ulcer (PU)
• Intervention / Treatment: Procedure: Photobiomodulation; Procedure: Standard-of-care ulcer dressing

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

1. 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?
2. Are factors such as sex, age, number of comorbid conditions, ulcer area, ulcer duration, and physical function associated with healing time?
3. What is the recurrence rate of hard-to-heal ulcers of respective aetiology at 6, 12, 18, and 24 months after healing with PBM?
4. How does patients self-assess pain and ulcer-related restraints during the photobiomodulation treatment period?
5. Is PBM treatment of hard-to-heal ulcers cost-effective compared to standard-of-care treatment in frail older adults?
6. How does healthcare provider experience treating hard-to-heal ulcers in frail older adults with PBM?

• Study Type: Interventional
• Enrollment (Actual): 1290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerbotten County
    • Skellefteå, Västerbotten County, Sweden, 93131
      • Skellefteå municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation; Photobiomodulation group, with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare	Procedure: Photobiomodulation; 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)
Active Comparator: Control group; Control groups from the RiksSår registry, with hard-to-heal ulcer diagnosed with a defined aetiology	Procedure: Standard-of-care ulcer dressing; Standard-of-care for hard-to-heal ulcer according to aetiology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing time: Time in days from initiation of PBM/(baseline registration) until healing.	Healing defined as intact skin in the previous ulcer area.	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.	From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic factors including: sex, age, number of comorbid conditions, ulcer area (at baseline), ulcer duration (at baseline), physical function.	Sex is divaded in women or men Age is number of years at baseline. Number of comorbid conditions extracted from patient record at baseline. Ulcer area measured as length x width in cm2 at baseline. Ulcer duration measured in number of weeks the patient have had the ulcer before initiation of photobiomodulation treatment or registration in the RiksSår registry. Physical function is assessed at baseline by a nurse, in the categories: walking, walking with assistance, wheelchair user/ bedbound.	Baseline
Changes in patient self-assessed general pain during photobiomodulation treatment time	Numeric rating scale from 0-10, 0 is no pain and 10 indicate worst possible pain	Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days.
Health economics: Estimated costs of providing photobiomodulation in comparistion to standard-of-care treatment	Esitmated costs are calculated based on 1) healthcare providers time for providing treatment, 2) frequency of treatment, 3) ulcer dressing material, 4) photobiomodulation equipment, 5) patients allocated time for taking part in treatment. Estimated costs are based on data from patient records, healing time and recurrence and compared to estimated costs for standad-of-care treatment.	Up to 4.5 years.
Changes in patient self-assessed ulcer pain during photobiomodulation treatment time	Numeric rateing scale, ratings 0-10 before removing ulcer dressing, 0 is no pain and 10 indicate worst possible pain.	Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days.
Changes in patient self-assessed ulcer-related physical restraints during photobiomodulation treatment time	Patient ulcer-related physical restraints (experienced physical restraints due to ulcer, for example unability to walk): Numeric rate scale ratings 0-10, 0 indicate no restraints and 10 indicate very severe restraints	Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days.
Changes in patient self-assessed ulcer-related experienced barriers and restraints during photobiomodulation treatment time	Patient ulcer-related experienced barriers and restraints (experienced barriers in everyday life and participation): Numeric rate scale ratings 0-10, 0 indicate no barriers/restraints and 10 indicate very severe barriers/restraints	Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days.

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Karolinska Institutet; Luleå University of Technology; Skellefteå Municipality
• Investigators: Principal Investigator: Åsa Audulv, PhD, Department of Nursing, Umeå University, Sweden

Publications and helpful links

General 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.
• Degerman 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.

Helpful Links

• Project webpage in Swedish: Kan medicinsk laser (laser photobiomodulation, PBM) stödja läkning av svårläkta sår hos sköra äldre i kommunal hälso- och sjukvård?

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: older adults; primary care; photobiomodulation; frail; home healthcare; hard-to-heal ulcer
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Pressure Ulcer; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 2020-02194 & 2024-00844-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No