Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers

NCT02222506 | Completed

• 1 other identifier: CL-K1002-P009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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 diabetic foot ulcers.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the KLOX BioPhotonic System in patients with diabetic foot 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.

  32 weeks

Secondary Outcomes (6)

• Optimal frequency of treatment with KLOX BioPhotonic System on diabetic foot ulcers.

  32 weeks

• Rate of complete wound closure.

  32 weeks

• Time to complete wound closure.

  32 weeks

• Incidence of wound breakdown.

  32 weeks

• Wound area reduction over time.

  32 weeks

Other Outcomes (1)

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

  32 weeks

Study Arms (1)

KLOX BioPhotonic System

EXPERIMENTAL

Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for diabetic foot 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 24 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for diabetic foot 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;
• Willing and able to adhere to an off-loading protocol. Patient must adhere to wearing orthopedic shoe for the study duration (from first day of Screening until end of study);
• Target cutaneous, full thickness ulcer with University of Texas classification I-A (superficial, non-infected, non-ischemic wound not involving tendon, capsules, or bone) or II-A (non-infected, non-ischemic wound penetrating to tendon or capsule but not in the bone or joint). A patient with more than one diabetic foot ulcer may be included in the trial but only one ulcer will be selected for the investigational treatment, based on investigator's judgment;
• Ulcer present for more than 4 weeks prior to study entry (Screening/Visit 1);
• Ulcer area between 1 and 16 cm2 inclusive. The maximum diameter of the wound must not exceed 8 cm;
• Diabetes mellitus (Type 1 or 2) with an A1C \< 12% at Screening;
• Diagnosis of neuropathic foot ulcer (10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area and/or biothesiometry or tuning fork 128 Hz);
• 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, or toe pressure \> 50 mmHg, or tcPO2 \> 40 mmHg).

You may not qualify if:

• Diabetic foot ulcer present for more than 12 months;
• Target ulcer is over a deformity (such as Charcot deformity) that interferes with off-loading based on investigator's opinion;
• Patient cannot tolerate off-loading method;
• 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);

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

Study Sites (3)

Q&T Research Chicoutimi

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

Centre de Recherche Clinique de Laval

Laval, Quebec, H7T 2P5, Canada

Location

Victoria Park MediSpa

Westmount, Quebec, H3Z 1C3, Canada

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

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: April 1, 2013
• Primary Completion: February 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

CA (3)