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Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers

NCT02222467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-02-23

No results posted yet for this study

Summary

The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with venous leg ulcers.

Conditions

  • Venous Leg Ulcers

Interventions

DEVICE

KLOX BioPhotonic System

KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for venous leg ulcers.

Sponsors & Collaborators

  • KLOX Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Andreas Nikolis, Dr · Victoria Park MediSpa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-04-30
Completion
2015-11-30

Countries

  • Canada

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 NCT02222467 on ClinicalTrials.gov