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

NCT07520825 | Active Not Recruiting

• 1 other identifier: 2020-02194 & 2024-00844-02
• Study Type: interventional
• Target: 1,290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hard-to-heal Wounds; Venous Leg Ulcer (VLU); Arterial Leg Ulcer; Pressure Ulcer (PU)

Keywords

home healthcare; older adults; frail; hard-to-heal ulcer; primary care; photobiomodulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Ulcer recurrence after healing with photobiomodulation treatment

  Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment.

Other Outcomes (6)

• Demographic factors including: sex, age, number of comorbid conditions, ulcer area (at baseline), ulcer duration (at baseline), physical function.

  Baseline

• Changes in patient self-assessed general pain during photobiomodulation treatment time

  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

  Up to 4.5 years.

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

Photobiomodulation group, with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare

Procedure: Photobiomodulation

Control group

ACTIVE COMPARATOR

Control groups from the RiksSår registry, with hard-to-heal ulcer diagnosed with a defined aetiology

Procedure: Standard-of-care ulcer dressing

Interventions

Photobiomodulation PROCEDURE

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)

Photobiomodulation

Standard-of-care ulcer dressing PROCEDURE

Standard-of-care for hard-to-heal ulcer according to aetiology.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Karolinska Institutet: collaborator
• Luleå University of Technology: collaborator
• Skellefteå Municipality: collaborator

Study Sites (1)

Skellefteå municipality

Skellefteå, Västerbotten County, 93131, Sweden

Location

Related Publications (2)

• 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.

  PMID: 41216935 RESULT

• 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.

  PMID: 36107964 RESULT

Related Links

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

MeSH Terms

Conditions

Varicose Ulcer; Pressure Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Åsa Audulv, PhD

  Department of Nursing, Umeå University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 9, 2026
• Study Start: September 1, 2020
• Primary Completion: May 30, 2023
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)