NCT02222454

Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers

A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: KLOX Technologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 stage II or III pressure ulcers.

Conditions

• Pressure Ulcers Stage II
• Pressure Ulcers Stage III

Interventions

Type	Name	Description
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 pressure ulcers.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-08-01
• First posted: 2014-08-21
• Last updated: 2016-02-23

Locations

4 sites across 1 country: Canada