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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
Adverse events, Serious Adverse Events and Device Incidents
Number of patients with adverse events, serious adverse events and device incidents.
Time frame: Up to 34 weeks
Rate of complete wound closure
Time frame: Up to 34 weeks
Wound area reduction over time
Time frame: Up to 34 weeks
Time to complete wound closure
Time frame: Up to 34 weeks
Incidence of wound breakdown, following wound closure
Time frame: Up to 34 weeks
Ease of use by healthcare professionals (questionnaire)
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 frame: Up to 34 weeks
Impact of treatment on Health-related Quality of Life (CWIS questionnaire)
To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System.
Time frame: Up to 34 weeks
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