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

NAUnknownINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 9, 2018

Primary Completion Date

March 31, 2020

Study Completion Date

June 30, 2020

Conditions
Venous Leg Ulcer
Interventions
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).

Trial Locations (1)

56126

RECRUITING

Clinica Dermatologica Azienda Ospedaliero-Universitaria Pisana, Pisa

Sponsors
All Listed Sponsors
lead

KLOX Technologies Inc.

INDUSTRY