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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 stage II or III pressure ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLOX BioPhotonic System | Experimental | Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for pressure ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLOX BioPhotonic System | Device | KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers. | Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers, with dosing flexibility according to Investigator's clinical opinion. | 24 weeks |
| Rate of complete wound closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of treatment on Health-related quality of life. | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Keast, Dr | Lawton Research Institute, London, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary Center for Clinical Research | Calgary | Alberta | T2N 4Z6 | Canada | ||
| Queen's University |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 24 weeks |
| Time to complete wound closure. | 24 weeks |
| Incidence of wound breakdown. | 24 weeks |
| Wound area reduction over time. | 24 weeks |
| Wound volume reduction over time. | 24 weeks |
| Kingston |
| Ontario |
| K7L 3N6 |
| Canada |
| Lawton Health Research Institute | London | Ontario | N6C 2R5 | Canada |
| St-Jerome Medical Research Inc. | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |