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Completed

NCT Number: NCT03021811

EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management

Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated written informed consent form;
  • Adult patient (at least 18 years old) having received a diagnosis of venous leg ulcer, diabetic foot ulcer or pressure ulcer by the Investigator;
  • The treating physician (investigator) believes the KLOX LumiHeal BioPhotonic System would be an appropriate option;
  • 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 comply with study requirements (visits, treatments, etc.).

Exclusion criteria

  • Female pregnant patient (by medical history or as ascertained by a pregnancy test);
  • Breast-feeding female patient;
  • Patients taking drugs/products (e.g., methotrexate, chemotherapy agents) or with conditions (e.g., porphyria) known to induce severe photosensitivity reactions;
  • Patients with known skin hypersensitivity.

Treatment and study plan

KLOX LumiHeal BioPhotonic System

Device

Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.

Other names: LumiHeal

Primary outcomes

  1. Adverse events, Serious Adverse Events and Device Incidents

    Time frame: Up to 34 weeks

    Number of patients with adverse events, serious adverse events and device incidents.

  2. Rate of complete wound closure

    Time frame: Up to 34 weeks

Secondary outcomes

  1. Wound area reduction over time

    Time frame: Up to 34 weeks

  2. Time to complete wound closure

    Time frame: Up to 34 weeks

  3. Incidence of wound breakdown, following wound closure

    Time frame: Up to 34 weeks

  4. Ease of use by healthcare professionals (questionnaire)

    Time frame: Up to 34 weeks

    To collect feedback on the ease of use of the KLOX LumiHeal BioPhotonic System in the management of chronic wounds, from health care professional users.

  5. Impact of treatment on Health-related Quality of Life (CWIS questionnaire)

    Time frame: Up to 34 weeks

    To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System.

Sponsors and collaborators

Lead sponsor

KLOX Technologies Inc.

Industry

Registry information

Official study title

EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 16, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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