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

No results posted yet for this study

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

  • Karolinska Institutet

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520825 on ClinicalTrials.gov