Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2016
• Main ID: NCT02222506
• Date of registration: 19/08/2014
• Prospective Registration: No
• Primary sponsor: KLOX Technologies Inc.
• Public title: Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers
• Scientific title: A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Diabetic Foot Ulcers
• Date of first enrolment: April 2013
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02222506
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Andreas Nikolis, Dr
• Affiliation: Victoria Park MediSpa

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Foot Ulcers

Intervention(s)

Device: KLOX BioPhotonic System

Primary Outcome(s)

Safety and tolerability of the KLOX BioPhotonic System in patients with diabetic foot ulcers. [Time Frame: 32 weeks]

Secondary Outcome(s)

Incidence of wound breakdown. [Time Frame: 32 weeks]

Optimal frequency of treatment with KLOX BioPhotonic System on diabetic foot ulcers. [Time Frame: 32 weeks]

Time to complete wound closure. [Time Frame: 32 weeks]

Wound area reduction over time. [Time Frame: 32 weeks]

Rate of complete wound closure. [Time Frame: 32 weeks]

Wound volume reduction over time. [Time Frame: 32 weeks]

Secondary ID(s)

CL-K1002-P009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors