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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Luleå University of Technology | UNKNOWN |
| Skellefteå Municipality | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photobiomodulation | Experimental | Photobiomodulation group, with hard-to-heal ulcer diagnosed with a defined aetiology, treated in municipal home healthcare |
|
| Control group | Active Comparator | Control groups from the RiksSår registry, with hard-to-heal ulcer diagnosed with a defined aetiology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation | Procedure | Photobiomodulation treatment in addition to standard-of-care ulcer dressings for hard-to-heal ulcer according to aetiology.
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing time: Time in days from initiation of PBM/(baseline registration) until healing. | Healing defined as intact skin in the previous ulcer area. | 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. | From start of treatment/registration and until the date of either healed ulcer or interrupted treatment/death assessed for up to 1000 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic factors including: sex, age, number of comorbid conditions, ulcer area (at baseline), ulcer duration (at baseline), physical function. | Sex is divaded in women or men Age is number of years at baseline. Number of comorbid conditions extracted from patient record at baseline. Ulcer area measured as length x width in cm2 at baseline. Ulcer duration measured in number of weeks the patient have had the ulcer before initiation of photobiomodulation treatment or registration in the RiksSår registry. Physical function is assessed at baseline by a nurse, in the categories: walking, walking with assistance, wheelchair user/ bedbound. |
Inclusion Criteria Intervention Arm:
Inclusion Criteria Control Arm:
Exclusion Criteria Intervention Arm:
Exclusion Criteria Control Arm:
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| Name | Affiliation | Role |
|---|---|---|
| Åsa Audulv, PhD | Department of Nursing, Umeå University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skellefteå municipality | Skellefteå | Västerbotten County | 93131 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41216935 | Result | Degerman M, Corneliusson L, Ohman M, Schmitt-Egenolf M, Bertilson BC, Audulv A. Photobiomodulation, Compared to Revascularisation, and Conservative Treatment-What Works for Healing Hard-to-Heal Arterial Leg Ulcers in Older Adults: A Quasi-Experimental Study. Wound Repair Regen. 2025 Nov-Dec;33(6):e70106. doi: 10.1111/wrr.70106. | |
| 36107964 |
| Label | URL |
|---|---|
| Project webpage in Swedish: Kan medicinsk laser (laser photobiomodulation, PBM) stödja läkning av svårläkta sår hos sköra äldre i kommunal hälso- och sjukvård? | View source |
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The dataset generated and analyzed during the current study is not publicly available because participant consent included restrictions on use of the data due to patients' privacy concerns. Limited availability is possible.
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| Standard-of-care ulcer dressing | Procedure | Standard-of-care for hard-to-heal ulcer according to aetiology. |
|
| Controlled in patient records 6, 12, 18, and 24 months after healing with photobiomodulation treatment. |
| Baseline |
| Changes in patient self-assessed general pain during photobiomodulation treatment time | Numeric rating scale from 0-10, 0 is no pain and 10 indicate worst possible pain | Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days. |
| Health economics: Estimated costs of providing photobiomodulation in comparistion to standard-of-care treatment | Esitmated costs are calculated based on 1) healthcare providers time for providing treatment, 2) frequency of treatment, 3) ulcer dressing material, 4) photobiomodulation equipment, 5) patients allocated time for taking part in treatment. Estimated costs are based on data from patient records, healing time and recurrence and compared to estimated costs for standad-of-care treatment. | Up to 4.5 years. |
| Changes in patient self-assessed ulcer pain during photobiomodulation treatment time | Numeric rateing scale, ratings 0-10 before removing ulcer dressing, 0 is no pain and 10 indicate worst possible pain. | Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days. |
| Changes in patient self-assessed ulcer-related physical restraints during photobiomodulation treatment time | Patient ulcer-related physical restraints (experienced physical restraints due to ulcer, for example unability to walk): Numeric rate scale ratings 0-10, 0 indicate no restraints and 10 indicate very severe restraints | Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days. |
| Changes in patient self-assessed ulcer-related experienced barriers and restraints during photobiomodulation treatment time | Patient ulcer-related experienced barriers and restraints (experienced barriers in everyday life and participation): Numeric rate scale ratings 0-10, 0 indicate no barriers/restraints and 10 indicate very severe barriers/restraints | Self-assessment was conducted every third week from start of treatment and until either the ulcer healed or treatment was interrupted. At longest patients could be followed for up to 1000 days. |
| Degerman M, Ohman M, Bertilson BC. Photobiomodulation, as additional treatment to traditional dressing of hard-to-heal venous leg ulcers, in frail elderly with municipality home healthcare. PLoS One. 2022 Sep 15;17(9):e0274023. doi: 10.1371/journal.pone.0274023. eCollection 2022. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |