Arterial Leg Ulcer, Hard-to-heal Wounds, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
Conditions
Keywords
home healthcare, older adults, frail, hard-to-heal ulcer, primary care, photobiomodulation
Brief 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?
Interventions
PROCEDUREPhotobiomodulation
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)
PROCEDUREStandard-of-care ulcer dressing
Standard-of-care for hard-to-heal ulcer according to aetiology.
Sponsors
Umeå University
Karolinska Institutet
Luleå University of Technology
Skellefteå Municipality
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing time: Time in days from initiation of PBM/(baseline registration) until healing. | From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days. | Healing defined as intact skin in the previous ulcer area. |
| Propotion of healed ulcers compared to other ulcer treatment events. | From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days. | Ulcers are either healed or censored due to death, amputation, or interrupted treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer recurrence after healing with photobiomodulation treatment | Controlled in patient records 6, 12, 18, and 24 months 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. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORÅsa Audulv, PhD
Department of Nursing, Umeå University, Sweden
Outcome results
None listed