Trial Outcomes & Findings for Blu Light for Ulcers Reduction (NCT NCT04018924)

Results Overview

The primary outcome of the study is the outcomes comparison as remaining wound area surface percentage difference of the lesion treated with EmoLED versus the lesion treated with SOC, both as difference on same patient and within the group of all recruited patients. The primary outcome is measured as the average of the ratio between final areas and initial areas; the ratio of 10 week wound surface area to initial wound surface area was multiplied by 100 to determine the percentage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

10 weeks

Results posted on

2021-05-19

Participant Flow

The total number of participants is 90 and the patient is control of himself.

Participant milestones

Participant milestones
Measure	All Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Overall Study STARTED	90
Overall Study Standard Of Care Intervention	90
Overall Study EmoLED Intervention	90
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=90 Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Age, Customized Age groups · < 49 years	7 Participants n=90 Participants
Age, Customized Age groups · 50 < years < 59	12 Participants n=90 Participants
Age, Customized Age groups · 60 < years < 69	16 Participants n=90 Participants
Age, Customized Age groups · 70 < years < 79	28 Participants n=90 Participants
Age, Customized Age groups · 80 < years <89	26 Participants n=90 Participants
Age, Customized Age groups · > 90 years	1 Participants n=90 Participants
Sex: Female, Male Female	49 Participants n=90 Participants
Sex: Female, Male Male	41 Participants n=90 Participants
Region of Enrollment Italy	90 participants n=90 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Non-compliant and dropout patients were excluded. Only patients whose images could be analyzed were considered in the analysis.

The primary outcome of the study is the outcomes comparison as remaining wound area surface percentage difference of the lesion treated with EmoLED versus the lesion treated with SOC, both as difference on same patient and within the group of all recruited patients. The primary outcome is measured as the average of the ratio between final areas and initial areas; the ratio of 10 week wound surface area to initial wound surface area was multiplied by 100 to determine the percentage.

Outcome measures

Outcome measures
Measure	All Participants n=67 Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Size of Wound Remaining Compared to Initial Wound Size EmoLED treated wound	42.58 percentage of the remaining area Standard Deviation 39.7
Size of Wound Remaining Compared to Initial Wound Size Control wound	53.78 percentage of the remaining area Standard Deviation 84.8

SECONDARY outcome

Timeframe: 10 weeks treatment or in case of adverse event until the patient status return to normal

Population: All Treatment-Emergent Adverse Events were systemic and cannot be attributed to one or the other intervention, due to the fact that all patients are also control of themselves.

Presence of any Adverse event during treatment period and after

Outcome measures

Outcome measures
Measure	All Participants n=90 Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Number of Participants With Treatment-Emergent Adverse Events	6 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: Non-compliant and dropout patients were excluded. Only patients whose images could be analyzed were considered in the analysis.

Outcomes comparison as percentage reduction of the lesion treated with EmoLED versus the lesion treated with SOC within ten weeks of the study. The measure of the outcome was calculated by the average of the medians of the weekly percentage reduction of the area, compared to the previous visit.

Outcome measures

Outcome measures
Measure	All Participants n=67 Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Weekly Comparison of Healing Percentage EmoLED treated wound	7.02 percentage of area reduction Standard Deviation 4.19
Weekly Comparison of Healing Percentage Control wound	3.06 percentage of area reduction Standard Deviation 3.72

SECONDARY outcome

Timeframe: 10 weeks

Population: Non-compliant and dropout patients were excluded. Only patients whose images could be analyzed were considered in the analysis.

Time difference measured in weeks to reach the healing. The analysis was conducted deriving the Kaplan-Meyer curves from the analysis of the healing time. The K-M curves describe the probability of healing at each control time.

Outcome measures

Outcome measures
Measure	All Participants n=67 Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Percentage of Recovered Wounds at 10 Weeks EmoLED treated wound	24 percentage of probability of recovery
Percentage of Recovered Wounds at 10 Weeks Control wound	18 percentage of probability of recovery

SECONDARY outcome

Timeframe: Week 1 and Week 10

Population: The analysis was carried out considering the subjects who have 11 assessments, until yhe 10th week. The pain cannot be attributable to one or the other intervention because the patient is control of themselves, so pain cannot be perceived separately by the individual.

pre-treatment evaluation with Visual Analogic Scale (0-10 scale with 0 as no pain and 10 as extreme pain) and comparison with the same scale measured at each treatment. The result is measured by writing the averages of Week 1 and of Week 10.

Outcome measures

Outcome measures
Measure	All Participants n=45 Participants The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Pain Change Visit 10	4.6 units on a scale
Pain Change Visit 0	7.2 units on a scale

SECONDARY outcome

Timeframe: 20 weeks

Population: It was at the discretion of the patient's willingness to continue the observation time after the 10 weeks of treatment. None of the patients that presented an unhealed area over the 10-week period decided to continue.

At the discretion of the patient's willingness to continue to visit the study site; observation of the unhealed area(s) over the 10-week period is extended until healing or up to 20 weeks.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=90 participants at risk The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Blood and lymphatic system disorders POA with critical stenosis	1.1% 1/90 • 15 months Adverse Events reported in this study cannot be attributed to one or the other intervention, due to the fact that they are systemic and all patients are also control of themselves.
Cardiac disorders Myocardial infarction and heart failure	1.1% 1/90 • 15 months Adverse Events reported in this study cannot be attributed to one or the other intervention, due to the fact that they are systemic and all patients are also control of themselves.
Cardiac disorders Acute myocardial infarction	1.1% 1/90 • 15 months Adverse Events reported in this study cannot be attributed to one or the other intervention, due to the fact that they are systemic and all patients are also control of themselves.
Skin and subcutaneous tissue disorders Hyperthermia/ Erysipelas	1.1% 1/90 • 15 months Adverse Events reported in this study cannot be attributed to one or the other intervention, due to the fact that they are systemic and all patients are also control of themselves.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.1% 1/90 • 15 months Adverse Events reported in this study cannot be attributed to one or the other intervention, due to the fact that they are systemic and all patients are also control of themselves.

Other adverse events

Other adverse events
Measure	All Participants n=90 participants at risk The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound). Control wound: After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week. EmoLED treated wound: After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week. Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device).
Skin and subcutaneous tissue disorders Fistulae	1.1% 1/90 • 15 months Adverse Events reported in this study cannot be attributed to one or the other intervention, due to the fact that they are systemic and all patients are also control of themselves.

Additional Information

Duccio Rossi Degl'Innocenti

Emoled

Phone: +39 0550751981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place