An interventional study of blue light photobiomodulation and cleansing in Pressure Sore, Pressure Ulcer and Pressure Ulcers Stage III, sponsored by Emoled. Completed at 1 site in Italy. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Emoled · Not applicable, Interventional, and Treatment
The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage decubitus lesion, comparing this method with the effectiveness of the therapy commonly used in the clinical field.
Pressure ulcers (PU), also known as decubitus sores, are areas of lesion localized to the skin and subcutaneous tissue. The development of decubitus ulcers occurs in institutional and community environments, and more frequently in assisted elderly, debilitated and motionless (e.g. orthopedic patients), in patients with severe acute disease (e.g. hospitalized in intensive care units) and in subjects with neurological deficits (e.g. spinal injuries).
Recognizing the considerable economic, health and social impact of pressure ulcers has led to considerable efforts to reduce their occurrence. Nevertheless, pressure ulcers continue to occur. Although not all pressure ulcers are iatrogenic, most of them can be prevented. Pressure ulcers are one of the most frequent iatrogenic lesions in developed countries.
Inadequate treatment methods, such as leaving vulnerable patients in potentially harmful positions for long periods, or massaging reddened skin areas, often continue to be perpetuated even if it has been proven that they are damaging or ineffective.
Pressure, that is often associated to a limitation in mobility of the patient, for a long time has been considered the most important extrinsic factor in the development of pressure ulcers.
However, recent research, and still ongoing, is revealing that shear forces, friction, and microclimate also play an important role in the etiology of pressure ulcers, and that, also, some significant and complex relationships between all these extrinsic factors exist.
In alert patients, the effects of prolonged pressure usually stimulate frequent light body movements to relieve the load and restore tissue perfusion. Unconscious, sedated, anesthetized or paralyzed patients cannot feel or respond to these stimuli and do not move spontaneously. As a result, skin and soft tissue can be exposed to prolonged and without relief pressure.
PUs are generally more common in anatomical locations that cover a bone prominence. In adults, the most common sites are the sacrum and the heel. Other frequently affected anatomical locations are ischium, ankle, elbow and hip.
Pressure ulcers are often difficult to diagnose, in particular it is easy to confuse them with moisture-caused injuries. A correct diagnosis is essential to determine both prevention and treatment plans.
For a proper management of pressure lesions it is essential to take into account their characteristics (location, color, size, amount of exudate, type of tissue, smell, edges) and to consider the condition of the peri-lesional skin (erythema, edema, hardening, maceration). To describe the state of a pressure ulcer, EPUAP (European Pressure Ulcer Advisory Panel) and NPUAP (National Pressure Ulcer Advisory Panel) recommend to divide pressure injuries stages from 1 to 4:
The commercial purpose of this study is to value the clinical efficacy of a battery-powered device that uses blue LEDs.
The study aims to compare the response of an existing standard treatment for second and third stage pressure sores, with a protocol that plans the administration of the EmoLED treatment three times a week for 4 consecutive weeks in addition to the conventional therapy.
The Study has an indicative duration of 12 months with an expected enrollment period of 10 months. The study, however, will continue until the number of patients required by this protocol is reached.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 48 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Emoled is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Control Group will follow the standard treatment indicated three times a week for the 4 weeks of observation. The standard treatment for 2° and 3° stage PU consists of: cleansing with saline or ringer's lactate, hyaluronic acid gauze plus polyurethane foam every 48 hours or as needed. In addition, zinc cream or hyaluronic acid sodium salt + metallic silver is applied to prevent and/or treat the skin maceration of the surrounding area, and eventual debridement of the lesion, application of topical treatment indicated for that stage of the lesion (as provided by the "Protocol on pressure ulcers' dressing" intended as the "standard of care" of the structure) and subsequent bandage (that generally consists of a polyurethane film -thin hydrocolloid plate or a pressure discharge system made with hydrocolloids and polyurethane foam, known as "pressure relief system"), are planned.
Procedure: cleansing · Combination Product: hyaluronic acid gauze plus polyurethane foam · Drug: zinc cream or hyaluronic acid sodium salt + metallic silver · Procedure: topical treatment · Procedure: bandage
The Experimental Group will undergo, in addition to the standard treatment, treatment with Emoled three times a week for 4 consecutive weeks. This treatment consists of irradiation with the blue light emitted by the device for one minute on the injured area. If the lesion has a greater extension than the irradiated area, multiple repeated applications will be performed, on adjacent areas, until the entire area is covered. The treatment with EmoLED will be carried out in correspondence with the dressing change of the lesion.
Device: blue light photobiomodulation · Procedure: cleansing · Combination Product: hyaluronic acid gauze plus polyurethane foam · Drug: zinc cream or hyaluronic acid sodium salt + metallic silver · Procedure: topical treatment · Procedure: bandage
1 minute irradiation of blue light performed with EmoLED device.
Also known as: EmoLED treatment
cleaning of the wound area with saline or ringer's lactate
every 48 hours or as needed
applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment indicated for that stage of the lesion
it consists of a polyurethane film -thin hydrocolloid plate or a pressure discharge system made with hydrocolloids and polyurethane foam, known as "pressure relief system"
Percentage Difference in PUSH Score
Change in the index of the PUSH scale of second and third stage ulcers (reflecting the assessment of the clinical state of the lesions) in the two treatment groups at the end of the 4-week observation period. PUSH (Pressure Ulcer Scale for Healing) score is the sum of three subscales measuring wound size (0 to 10), exudate amount (0 to 3) and tissue type (0 to 4). The sum total ranges from 0 (best outcome) to 17 (worst outcome).The change in PUSH scale scores is determined by comparing the mean value at baseline with the final (4-weeks) mean value of the scores obtained for each arm. The comparison was performed by calculating the percentage reduction of the two values; this means that a positive percentage indicates a reduction in the mean values of the PUSH scale and a consequent improvement of the ulcer.
Time frame: 4 weeks
Change of the Lesion Area
The assessment, during the weeks of observation, of change of the lesion area compared to V0 in the second and third stage lesions in both arms, measured as % of the initial size.The change in ulcer areas is determined by comparing the mean value at baseline with the final (4-week) mean value of areas calculated for each arm. The comparison was performed by calculating the percentage reduction of the two values; this means that a positive percentage indicates a reduction in the mean values of the lesion areas and a consequent improvement of the ulcer.
Time frame: 4 weeks
Number of Treatment-Emergent Adverse Events
Safety of treatment (number of related adverse events in the two groups). All incidents according to the definition of the EU regulation 2017/745 on Medical Devices will be properly reported their gravity and relation with the therapy evaluated. It will be counted the number and gravity of occurred adverse events on both arms
Time frame: 4 weeks
| Milestone | Control Group | EmoLED Group |
|---|---|---|
| Started | 24 | 24 |
| Completed | 20 | 20 |
| Not completed | 4 | 4 |
Change in the index of the PUSH scale of second and third stage ulcers (reflecting the assessment of the clinical state of the lesions) in the two treatment groups at the end of the 4-week observation period. PUSH (Pressure Ulcer Scale for Healing) score is the sum of three subscales measuring wound size (0 to 10), exudate amount (0 to 3) and tissue type (0 to 4). The sum total ranges from 0 (best outcome) to 17 (worst outcome).The change in PUSH scale scores is determined by comparing the mean value at baseline with the final (4-weeks) mean value of the scores obtained for each arm. The comparison was performed by calculating the percentage reduction of the two values; this means that a positive percentage indicates a reduction in the mean values of the PUSH scale and a consequent improvement of the ulcer.
| percentage reduction of PUSH score | Control Group | EmoLED Group |
|---|---|---|
| Percentage Difference in PUSH Score | 23.1 ± 16.5 | 39.1 ± 30.0 |
The assessment, during the weeks of observation, of change of the lesion area compared to V0 in the second and third stage lesions in both arms, measured as % of the initial size.The change in ulcer areas is determined by comparing the mean value at baseline with the final (4-week) mean value of areas calculated for each arm. The comparison was performed by calculating the percentage reduction of the two values; this means that a positive percentage indicates a reduction in the mean values of the lesion areas and a consequent improvement of the ulcer.
| percentage of reduction | Control Group | EmoLED Group |
|---|---|---|
| Change of the Lesion Area | 29.8 ± 27.3 | 52.5 ± 15.6 |
Safety of treatment (number of related adverse events in the two groups). All incidents according to the definition of the EU regulation 2017/745 on Medical Devices will be properly reported their gravity and relation with the therapy evaluated. It will be counted the number and gravity of occurred adverse events on both arms
| Number of adverse events | Control Group | EmoLED Group |
|---|---|---|
| Number of Treatment-Emergent Adverse Events | 0 | 0 |
Collected over From the time of enrollment to the last visit under the protocol (4 weeks, or less in case of healing). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) |
| EmoLED Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Event | Control Group | EmoLED Group |
|---|---|---|
| Cardiac arrestCardiac disorders | 1/24 | 0/24 |
| Age, Continuous(years) | Control Group | EmoLED Group | Total |
|---|---|---|---|
| Median | 75.5 (50 to 91) | 75 (55 to 89) | 75 (50 to 91) |
| Sex: Female, Male(Participants) | Control Group | EmoLED Group | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 17 | 16 | 33 |
| Race and Ethnicity Not Collected(Participants) | Control Group | EmoLED Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control Group | EmoLED Group | Total |
|---|---|---|---|
| Italy | 24 | 24 | 48 |
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