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The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU). Patients will be randomized in three groups, two different dispensing schedules of KLOX BioPhotonic System in addition to Standard of Care (SOC) will be used, and SOC alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLOX BioPhotonic System (single treatment)+SOC | Experimental | KLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered twice weekly in association with SOC (10 patients) |
|
| KLOX BioPhotonic System (consecutive treatments)+SOC | Experimental | KLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered in two consecutive treatments (twice weekly on the first two weeks then once weekly) in association with SOC (10 patients) |
|
| Standard of Care | Active Comparator | SOC only (5 patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLOX BioPhotonic System (single treatment)+SOC | Device | KLOX BioPhotonic system (composed of LumiHeal Gel and KT-L Lamp). In this study arm one treatment will be assessed - two visits per week. Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of biomarkers expression in biopsies and exudates of the venous leg ulcers. | Comparison of the expression of biomarkers in biopsies and exudates of the venous leg ulcers in the three treatment groups. | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, Serious adverse events, device incidents and compliance. | Number of adverse events, serious adverse events, device incidents and missed treatment visits. | Up to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephane Fauverghe, MD | Contact | 450-680-4389 | sfauverghe@kloxtechnologies.com |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Dini, MD | Azienda Ospedaliero, Universitaria Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dermatologica Azienda Ospedaliero-Universitaria Pisana | Recruiting | Pisa | 56126 | Italy |
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| KLOX BioPhotonic System (consecutive treatments)+SOC | Device | In this study arm, two consecutive treatments during the same visit will be evaluated- two visits for the first two weeks, then one visit per week. Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks). |
|
| Standard of Care (SOC) | Other | Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks). |
|
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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