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Diabetic Foot UlcersNCT02222506

Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers

A study testing KLOX BioPhotonic System in people with Diabetic Foot Ulcers, run by KLOX Technologies Inc. at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcers
What is being tested?
KLOX BioPhotonic System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesCanada
Study dates
Apr 2013to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Q&T Research Chicoutimi

    Chicoutimi, Quebec, G7H 7Y8

  • Centre de Recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Victoria Park MediSpa

    Westmount, Quebec, H3Z 1C3

Other trials in Canada

About this study

Official title: 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.

Being tested
KLOX BioPhotonic System
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KLOX BioPhotonic SystemDevice

    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.

Study groups in NCT02222506
Study groupRoleWhat they receive
KLOX BioPhotonic SystemExperimentalTreatment with KLOX BioPhotonic System in adjunction to Standard Of Care for diabetic foot ulcers.
Receives: Device: KLOX BioPhotonic System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 32 weeks

Secondary outcomes (6)

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

    Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on diabetic foot ulcers, with dosing flexibility according to Investigator's clinical opinion.

    Measured: 32 weeks

  2. Rate of complete wound closure.

    Measured: 32 weeks

  3. Time to complete wound closure.

    Measured: 32 weeks

  4. Incidence of wound breakdown.

    Measured: 32 weeks

  5. Wound area reduction over time.

    Measured: 32 weeks

  6. Wound volume reduction over time.

    Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02222506
Sponsor's protocol ID
CL-K1002-P009
Status last verified
Sep 2016
First submitted
19 Aug 2014
Last updated
5 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing KLOX BioPhotonic System in people with Diabetic Foot Ulcers, run by KLOX Technologies Inc. at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of the KLOX BioPhotonic System in patients with diabetic foot ulcers. (time frame: 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02222506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.

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