Phase 1 Study Of A Novel Wearable Phototherapy System For The Management Of Chronic Venous Leg Ulcers
Samuel Hill1, Matthew Regulski2, Gary Rogers1.
1Rogers Sciences, Inc., Boston, MA, USA, 2Ocean County Foot & Ankle, Toms River, NJ, USA.
BACKGROUND Chronic wounds frequently become colonized with biofilm-producing microbes resistant to treatment with antibiotics. These infected wounds are susceptible to excessive and prolonged inflammation and are not able to respond to normal epithelial migration and cellular proliferation stimuli. Antimicrobials, hydrogels, and enzymatic debridement ointments are often applied but can inhibit wound healing. The delivery of photobiomodulation to a chronic wound site is a promising alternative. In-vitro, as well as published animal and human studies indicates specific wavelengths of visible light have antimicrobial effects on gram positive and negative bacteria, fungi and multi-drug resistant organisms in conjunction with stimulating wound healing. METHODS A Phase 1 clinical study was undertaken to evaluate a Continuous Low-Irradiance Phototherapy (CLIP) system that emits blue (<430nm) light via a handheld powerpack attached to a single-use (28-day period) light-emitting patch, worn continuously. The study evaluates safety and efficacy of the CLIP system on 10 adult pts. presenting with venous leg ulcers or diabetic foot ulcers that failed to close >30% with standard of care (SOC) over a 2-week screening period. RESULTS Endpoints include monitoring adverse events; re-epithelialization based on percentage area reduction; bioburden; and inflammation as evaluated by digital imaging and wound swabs; and evaluation of pain at rest and during application-inspection of the light-emitting patch at clinic visits. CONCLUSION To date 7-patients have been accrued with no adverse events and reduced pain levels. Initial data indicates that the CLIP therapy has been able to reduce bioburden and inflammation and increase re-epithelialization. The potential of continuous, wearable, home-based photobiomodulation may provide a new and effective wound healing treatment option.
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