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

NCT03593369 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-14

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • KLOX Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Valentina Dini, MD · Azienda Ospedaliero, Universitaria Pisana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2020-03-31
Completion
2020-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593369 on ClinicalTrials.gov