Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07520825

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hard-to-heal Wounds Arterial Leg Ulcer Cardiovascular Diseases Leg Ulcer Pressure Ulcer Pressure Ulcer (PU) Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Leg Ulcer (VLU)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skellefteå municipality

Skellefteå, Västerbotten County, 93131, Sweden

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Standard-of-care ulcer dressing

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Ulcer recurrence after healing with photobiomodulation treatment

    Time frame: Controlled in patient records 6, 12, 18, and 24 months 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.

Other outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: 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.

    Numeric rating scale from 0-10, 0 is no pain and 10 indicate worst possible pain

  3. Health economics: Estimated costs of providing photobiomodulation in comparistion to standard-of-care treatment

    Time frame: Up to 4.5 years.

    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.

  4. Changes in patient self-assessed ulcer pain during photobiomodulation treatment time

    Time frame: 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.

    Numeric rateing scale, ratings 0-10 before removing ulcer dressing, 0 is no pain and 10 indicate worst possible pain.

  5. Changes in patient self-assessed ulcer-related physical restraints during photobiomodulation treatment time

    Time frame: 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.

    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

  6. Changes in patient self-assessed ulcer-related experienced barriers and restraints during photobiomodulation treatment time

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Karolinska Institutet
  • Luleå University of Technology
  • Skellefteå Municipality

Registry information

Official study title

Laser Photobiomodulation in Addition to Standard-of-care for Hard-to-heal Ulcers in Frail Older Adults With Municipality Home Healthcare

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.