Trial Outcomes & Findings for Leg Ulcers Standards of Care Enhancement (NCT NCT04689009)
NCT ID: NCT04689009
Last Updated: 2025-05-09
Results Overview
It is expected to demonstrate the equivalence between EmoLED Group treatment (consisting in EmoLED treatment + SOC treatment, once a week) and SOC Group treatment (consisting in SOC treatment, twice a week), in terms of percentage change of the wound area, at week 16 and at Follow-up visit (at week 20) from baseline. The percentage reduction is measured by calculating: (initial area of the wound - final area of the wound) / initial area of the wound x 100.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Baseline,16 weeks, 20 weeks
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
SOC Group
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
34
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
SOC Group
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SOC Group
n=41 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=42 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=83 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=41 Participants
|
11 Participants
n=42 Participants
|
17 Participants
n=83 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=41 Participants
|
31 Participants
n=42 Participants
|
66 Participants
n=83 Participants
|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 10.06 • n=41 Participants
|
73.6 years
STANDARD_DEVIATION 11.83 • n=42 Participants
|
75.3 years
STANDARD_DEVIATION 11.8 • n=83 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=41 Participants
|
24 Participants
n=42 Participants
|
47 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=41 Participants
|
18 Participants
n=42 Participants
|
36 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
41 participants
n=41 Participants
|
42 participants
n=42 Participants
|
83 participants
n=83 Participants
|
PRIMARY outcome
Timeframe: Baseline,16 weeks, 20 weeksPopulation: Per Protocol population
It is expected to demonstrate the equivalence between EmoLED Group treatment (consisting in EmoLED treatment + SOC treatment, once a week) and SOC Group treatment (consisting in SOC treatment, twice a week), in terms of percentage change of the wound area, at week 16 and at Follow-up visit (at week 20) from baseline. The percentage reduction is measured by calculating: (initial area of the wound - final area of the wound) / initial area of the wound x 100.
Outcome measures
| Measure |
SOC Group
n=34 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=37 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Percentage Change of the Wound Area
Area variation at week 16 from baseline
|
42.41 percentage of change
Standard Error 24.58
|
60.75 percentage of change
Standard Error 26.29
|
|
Percentage Change of the Wound Area
Area variation at week 20 from baseline
|
25.18 percentage of change
Standard Error 26.45
|
72.16 percentage of change
Standard Error 30.59
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Per Protocol population
Evaluation of the healing time of the lesions treated with the standard method (SOC Group) versus the lesions treated with the EmoLED (EmoLED Group), through the Data Collection Form, considering the elapsed time between the first visit and the event of interest (the reaching of healing)
Outcome measures
| Measure |
SOC Group
n=34 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=37 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Healing Time Evaluation
|
2.16 percent change per week
Standard Error 0.333
|
3.45 percent change per week
Standard Error 0.319
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Patients who filled the first and the last questionnaire
Difference of the life quality (QoL) score at 16 week minus the baseline score (week1) assessed by Wound-Qol3 questionnaire (value 0 indicates the best level of quality of life, 4 the worst).
Outcome measures
| Measure |
SOC Group
n=38 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=35 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Incidence of the Treatment (Standard vs EmoLED Protocol) in Life Quality
|
0.6 Score difference
Standard Deviation 0.7
|
0.7 Score difference
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Patients who filled the economic questionnaire
Evaluation of costs related to the EmoLED Group and SOC Group, in both the NHS and society perspective, through economic-organizational impact survey. The costs are reported per patient per study period.
Outcome measures
| Measure |
SOC Group
n=38 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=42 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Costs Related Evaluation
|
7,313 Euros
|
3,076 Euros
Interval 451.0 to
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Per Protocol population
Change of perceived pain through VAS scale ("Visual Analog Scale" in which 0 is the minimum value and the better outcome, and 10 is the maximum value and worse outcome) in both groups.
Outcome measures
| Measure |
SOC Group
n=25 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=29 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Percent Change in VAS Scale Evaluation
|
65.20 percentage change
Standard Deviation 40.25
|
77.76 percentage change
Standard Deviation 39.72
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Healthcare personnel who filled the satisfaction questionnaire
Evaluation of satisfaction, complexity and helpfulness of EmoLED device, considering both the perspective of patients, and the one of doctors and health care providers involved through a survey on the usability of the device (SUS - System Usability Scale, which includes 10 questions. Participants will classify each question from 1 to 5 based on how much they agree with the statement they are reading. 5 means they agree completely, 1 means they disagree vehemently).
Outcome measures
| Measure |
SOC Group
n=9 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Satisfaction, Complexity and Helpfulness Evaluation of the Device Assessed by SUS
|
3.96 units on a scale (1 worst - 5 best)
Standard Deviation 0.33
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Patients who filled the economic questionnaire
Evaluation of cost-effectiveness using EmoLED in the treatment of ulcers through economic-organizational impact survey. To calculate cost-effectiveness, the cost differential, between EmoLED group and Control group, was evaluated in terms of quality adjusted life years (QALY), obtaining the Incremental Cost-Effectiveness Ratio (ICER).
Outcome measures
| Measure |
SOC Group
n=38 Participants
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=42 Participants
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Cost-effectiveness Evaluation
|
1934.13 Euro/QALY
|
758.50 Euro/QALY
|
Adverse Events
SOC Group
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
EmoLED Group
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SOC Group
n=41 participants at risk
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=42 participants at risk
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erysipelas
|
2.4%
1/41 • Number of events 1 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
0.00%
0/42 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/41 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
2.4%
1/42 • Number of events 1 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
2.4%
1/41 • Number of events 1 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
0.00%
0/42 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
Other adverse events
| Measure |
SOC Group
n=41 participants at risk
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
EmoLED Group
n=42 participants at risk
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.
EmoLED: The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
current Standards Of Care: The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bullous pemphigoid
|
0.00%
0/41 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
2.4%
1/42 • Number of events 1 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
|
Skin and subcutaneous tissue disorders
Erythematous dermatitis
|
2.4%
1/41 • Number of events 1 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
0.00%
0/42 • From the time of enrollment to the last visit under the protocol (16 weeks, or less in case of healing)
|
Additional Information
Dr. Rossi Degl'Innocenti Duccio, Clinical Affairs Manager
EMOLED SRL
Phone: +390550751960
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will not disclose information about the Trial without the consent of the Sponsor. These confidentiality obligations will remain in force until the information is made public by the Promoter. The PI must submit the manuscript to the Promoter, at least 60 days before publication. The Sponsor will then have 45 days to suggest changes to the Investigator.
- Publication restrictions are in place
Restriction type: OTHER