Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer
Conditions
Brief summary
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).
Interventions
DEVICEKLOX LumiHeal BioPhotonic System
Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
Sponsors
KLOX Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events, Serious Adverse Events and Device Incidents | Up to 34 weeks | Number of patients with adverse events, serious adverse events and device incidents. |
| Rate of complete wound closure | Up to 34 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound breakdown, following wound closure | Up to 34 weeks | — |
| Wound area reduction over time | Up to 34 weeks | — |
| Impact of treatment on Health-related Quality of Life (CWIS questionnaire) | Up to 34 weeks | To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System. |
| Ease of use by healthcare professionals (questionnaire) | 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. |
| Time to complete wound closure | Up to 34 weeks | — |
Outcome results
None listed