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

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.

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?

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.