Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults
NCT07520825 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1290
Last updated 2026-04-09
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)
Interventions
- 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)
- PROCEDURE
-
Standard-of-care ulcer dressing
Standard-of-care for hard-to-heal ulcer according to aetiology.
Sponsors & Collaborators
- collaborator OTHER
-
Luleå University of Technology
collaborator UNKNOWN -
Skellefteå Municipality
collaborator UNKNOWN -
Umeå University
lead OTHER
Principal Investigators
-
Åsa Audulv, PhD · Department of Nursing, Umeå University, Sweden
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2023-05-30
- Completion
- 2027-05-01
Countries
- Sweden
Study Locations
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