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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LumiHeal | Other | Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLOX LumiHeal BioPhotonic System | Device | Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, Serious Adverse Events and Device Incidents | Number of patients with adverse events, serious adverse events and device incidents. | Up to 34 weeks |
| Rate of complete wound closure | Up to 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound area reduction over time | Up to 34 weeks | |
| Time to complete wound closure | Up to 34 weeks | |
| Incidence of wound breakdown, following wound closure |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| 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. | 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. | Up to 34 weeks |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |