NCT03593369

Assessment of the Evolution of Wound Biomarkers in Venous Leg Ulcers Treated With KLOX Biophotonic System

A Prospective Controlled Randomized Clinical Study Exploring The Evolution Of Wound Biomarkers With TWO Dispensing Schedules Of The KLOX LumiHeal Gel And The KT-L Lamp Versus Standard Of Care In Venous Leg Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: KLOX Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	KLOX BioPhotonic System (single treatment)+SOC	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).
DEVICE	KLOX BioPhotonic System (consecutive treatments)+SOC	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).
OTHER	Standard of Care (SOC)	Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks).

Timeline

• Start date: 2018-07-09
• Primary completion: 2020-03-01
• Completion: 2020-06-01
• First posted: 2018-07-20
• Last updated: 2019-08-14

Locations

1 site across 1 country: Italy