NCT07520825

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,290 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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?

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-05-30
• Completion: 2027-05-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Sweden