Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers

NCT02222467 | Completed

• 1 other identifier: CL-K1002-P008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the KLOX BioPhotonic System in patients with venous leg ulcers.

  Occurrence of adverse events, serious adverse events and incidents; pain assessment with Visual Analog Scale; clinical laboratory parameters; vital signs; physical examination; percentage of patients with clinical infection requiring systemic antimicrobial therapy; concomitant medications and treatments.

  24 weeks

Secondary Outcomes (6)

• Optimal frequency of treatment with KLOX BioPhotonic System on venous leg ulcers.

  24 weeks

• Rate of complete wound closure.

  24 weeks

• Time to complete wound closure.

  24 weeks

• Incidence of wound breakdown.

  24 weeks

• Wound area reduction over time.

  24 weeks

Other Outcomes (1)

• Impact of treatment on Health-related quality of life.

  24 weeks

Study Arms (1)

Klox BioPhotonic System

EXPERIMENTAL

Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for venous leg ulcers.

Device: KLOX BioPhotonic System

Interventions

KLOX BioPhotonic System DEVICE

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.

Klox BioPhotonic System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years of age and older;
• The subject or legal guardian must have signed an informed consent form;
• Female of child bearing potential must have a negative pregnancy test result at Baseline and both male and female patients must be willing to adhere to a medically-accepted birth control method during the course of the study;
• Willingness to return for all study visits;
• Proven venous leg ulcer, clinically defined and confirmed by duplex, refilling time or venous hypertension;
• Open venous leg ulcer present for more than 4 weeks prior to study entry (Screening/Visit 1);
• Ulcer area between 5 and 100 cm2 inclusive, with a maximum depth of 1 cm. The maximum diameter of the wound must not exceed 10 cm;
• Wound area has not changed by more than +/- 30% between Screening visit and Week 1/Visit 1 (before treatment).
• Adequate arterial blood perfusion (ABI (ankle brachial index) between 0.7 and 1.3, inclusive).

You may not qualify if:

• Venous leg ulcer present for more than 12 months;
• The ulcer to be treated is planned for operative debridement;
• The ulcer has significant necrotic tissue (e.g., more than 20% of the ulcer area);
• Major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia;
• Severe or significant hypoalbuminemia (albuminemia \< 30 g/L, and/or pre-albumin \< 5 mg/dL), or hypoproteinemia (proteinemia \< 55g/L);
• Patient with moderate to severe anemia (Hb \< 90g/L);
• Patient currently treated for an active malignant disease;
• Patient with history of malignancy within the wound;
• Patient with history of radiation therapy to the wound region;
• Patient with prior diagnosis of active malignant disease who is less than 1 year disease-free;
• Patient with a known osteomyelitis or active cellulitis;
• Patients that are immunosuppressed or on high dose chronic steroid use;
• Patients on systemic corticosteroids (a completion of corticosteroid course at least 30 days prior to study enrolment is required);
• Patient with active or systemic infection (note that the patient is however eligible for re-screening after the systemic infection has subsided);
• Successful revascularization surgery of the leg with the ulcer to be treated less than 8 weeks prior to Screening;

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

Study Sites (4)

Centre de Medecine Integrative et Evolutive

Brossard, Quebec, J4Z 1A7, Canada

Location

Q&T Research Chicoutimi

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

St-Jerome Medical Research Inc.

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Victoria Park MediSpa

Westmount, Quebec, H3Z 1C3, Canada

Location

Study Officials

• Andreas Nikolis, Dr

  Victoria Park MediSpa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: November 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

CA (4)