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

N/AActive Not RecruitingNCT07520825

Umeå University1,290 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,290

Conditions

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

Interventions

PhotobiomodulationPROCEDURE

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 dressingPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Skellefteå municipality

Skellefteå, Västerbotten County, Sweden

Outcomes

Primary Outcomes

Healing time: Time in days from initiation of PBM/(baseline registration) until healing.

Healing defined as intact skin in the previous ulcer area.

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.

Propotion of healed ulcers compared to other ulcer treatment events.

Ulcers are either healed or censored due to death, amputation, or interrupted treatment.

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.

Secondary Outcomes

Ulcer recurrence 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.

Time frame: Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment.

Data from ClinicalTrials.gov

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