Trial Outcomes & Findings for EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers (NCT NCT05130814)
NCT ID: NCT05130814
Last Updated: 2025-01-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Control Group
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.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
EmoLED Group
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.
blue light photobiomodulation: 1 minute irradiation of blue light performed with EmoLED device.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=24 Participants
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.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
EmoLED Group
n=24 Participants
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.
blue light photobiomodulation: 1 minute irradiation of blue light performed with EmoLED device.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.5 years
n=24 Participants
|
75 years
n=24 Participants
|
75 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
15 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
33 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Per Protocol Analysis
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.
Outcome measures
| Measure |
Control Group
n=20 Participants
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.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
EmoLED Group
n=20 Participants
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.
blue light photobiomodulation: 1 minute irradiation of blue light performed with EmoLED device.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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
|
23.1 percentage reduction of PUSH score
Standard Error 16.5
|
39.1 percentage reduction of PUSH score
Standard Error 30.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Patients with good quality lesion images for image analysis
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.
Outcome measures
| Measure |
Control Group
n=13 Participants
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.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
EmoLED Group
n=15 Participants
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.
blue light photobiomodulation: 1 minute irradiation of blue light performed with EmoLED device.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
|---|---|---|
|
Change of the Lesion Area
|
29.8 percentage of reduction
Standard Error 27.3
|
52.5 percentage of reduction
Standard Error 15.6
|
SECONDARY outcome
Timeframe: 4 weeksSafety 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
Outcome measures
| Measure |
Control Group
n=24 Participants
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.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
EmoLED Group
n=24 Participants
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.
blue light photobiomodulation: 1 minute irradiation of blue light performed with EmoLED device.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
|---|---|---|
|
Number of Treatment-Emergent Adverse Events
|
0 Number of adverse events
|
0 Number of adverse events
|
Adverse Events
Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
EmoLED Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=24 participants at risk
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.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
EmoLED Group
n=24 participants at risk
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.
blue light photobiomodulation: 1 minute irradiation of blue light performed with EmoLED device.
cleansing: cleaning of the wound area with saline or ringer's lactate
hyaluronic acid gauze plus polyurethane foam: every 48 hours or as needed
zinc cream or hyaluronic acid sodium salt + metallic silver: applied to prevent and/or treat the skin maceration of the surrounding area
topical treatment: topical treatment indicated for that stage of the lesion
bandage: 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"
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
4.2%
1/24 • Number of events 1 • From the time of enrollment to the last visit under the protocol (4 weeks, or less in case of healing)
|
0.00%
0/24 • From the time of enrollment to the last visit under the protocol (4 weeks, or less in case of healing)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place