- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222506
Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers
September 1, 2016 updated by: KLOX Technologies Inc.
A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Diabetic Foot Ulcers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7Y8
- Q&T Research Chicoutimi
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Laval, Quebec, Canada, H7T 2P5
- Centre de Recherche Clinique de Laval
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Westmount, Quebec, Canada, H3Z 1C3
- Victoria Park Medispa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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);
- 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;
- Patients with severely uncontrolled diabetes mellitus (defined as A1C > 12%);
- Raynaud disease or other severe peripheral microvascular disease;
- Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease);
- Active bleeding;
- Pregnancy, or breast feeding;
- Patients with bleeding diathesis;
- Patients on Warfarin or IV Heparin;
- The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study (e.g., severe morbid obesity, recent hip fracture, suspected non-compliance, etc.);
- Patients with ulcers from burns (from exposure to high heat), pressure ulcers or venous leg ulcers;
- Concurrent disease or drugs known to induce severe photosensitivity of the skin, such as porphyria;
- Patient has received biological-based therapy in any wound within 3 months of Screening;
- Concurrent participation in another clinical trial that involves an investigational drug or device that wound interfere with this study;
- Previous participation in other interventional wound healing clinical investigation within the 60 days prior to Screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KLOX BioPhotonic System
Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for diabetic foot ulcers.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of the KLOX BioPhotonic System in patients with diabetic foot ulcers.
Time Frame: 32 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal frequency of treatment with KLOX BioPhotonic System on diabetic foot ulcers.
Time Frame: 32 weeks
|
Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on diabetic foot ulcers, with dosing flexibility according to Investigator's clinical opinion.
|
32 weeks
|
Rate of complete wound closure.
Time Frame: 32 weeks
|
32 weeks
|
|
Time to complete wound closure.
Time Frame: 32 weeks
|
32 weeks
|
|
Incidence of wound breakdown.
Time Frame: 32 weeks
|
32 weeks
|
|
Wound area reduction over time.
Time Frame: 32 weeks
|
32 weeks
|
|
Wound volume reduction over time.
Time Frame: 32 weeks
|
32 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Impact of treatment on Health-related quality of life.
Time Frame: 32 weeks
|
32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andreas Nikolis, Dr, Victoria Park Medispa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
August 19, 2014
First Submitted That Met QC Criteria
August 19, 2014
First Posted (Estimate)
August 21, 2014
Study Record Updates
Last Update Posted (Estimate)
September 5, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-K1002-P009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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