Laser Photobiomodulation in Addition to Standard-of-care for Hard-to-heal Ulcers in Frail Older Adults With Municipality Home Healthcare
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,290
- 试验地点
- 1
- 主要终点
- Healing time: Time in days from initiation of PBM/(baseline registration) until healing.
研究概览
简要总结
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.
详细描述
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
- 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?
- Are factors such as sex, age, number of comorbid conditions, ulcer area, ulcer duration, and physical function associated with healing time?
- What is the recurrence rate of hard-to-heal ulcers of respective aetiology at 6, 12, 18, and 24 months after healing with PBM?
- How does patients self-assess pain and ulcer-related restraints during the photobiomodulation treatment period?
- Is PBM treatment of hard-to-heal ulcers cost-effective compared to standard-of-care treatment in frail older adults?
- How does healthcare provider experience treating hard-to-heal ulcers in frail older adults with PBM?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Photobiomodulation
Photobiomodulation group, with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare
干预措施: Photobiomodulation (Procedure)
Control group
Control groups from the RiksSår registry, with hard-to-heal ulcer diagnosed with a defined aetiology
干预措施: Standard-of-care ulcer dressing (Procedure)
结局指标
主要结局
Healing time: Time in days from initiation of PBM/(baseline registration) until healing.
时间窗: 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.
时间窗: 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.
次要结局
- Ulcer recurrence after healing with photobiomodulation treatment(Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment.)