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

NCT02222454 | Completed

• 1 other identifier: CL-K1002-P006
• Study Type: interventional
• Target: 3
• 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 stage II or III pressure ulcers.

Conditions

Pressure Ulcers Stage II; Pressure Ulcers Stage III

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure 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 stage II and III pressure 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 pressure 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 pressure 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;
• Stage II or III pressure ulcer (as per NPUAP Staging Guidelines), present for more than 4 weeks (up to Screening visit), located in the ischial, trochanteric, coccygeal, thoracic or abdominal regions. Lower extremity pressure ulcers, such as heel ulcers, are acceptable provided that diabetic foot ulcers are ruled out if the patient has diabetes. Surface dimensions of ulcer must be between 2 to 64 cm2 inclusive but longest diameter must not exceed 10 cm. Depth must not exceed 5 cm;
• Wound area has not changed by more than +/- 30% between Screening visit and Week 1/Visit 1 (before treatment).

You may not qualify if:

• Pressure ulcer present for more than 18 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);
• Patients with severely uncontrolled diabetes mellitus (defined as A1C \> 12%);

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

Study Sites (4)

Calgary Center for Clinical Research

Calgary, Alberta, T2N 4Z6, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Lawton Health Research Institute

London, Ontario, N6C 2R5, Canada

Location

St-Jerome Medical Research Inc.

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Keast, Dr

  Lawton Research Institute, London, Ontario, Canada

  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: August 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

CA (4)