Clinical Trial

Safety and Efficacy of the Noxsano Wound Care Bandage

Study Description

Safety and Efficacy of the Noxsano Wound Care Bandage

This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - Noxsano Bandage (Healthy Volunteers)

Healthy volunteers will wear the study device (Noxsano Bandage) for 3 consecutive days (up to 72 hours), followed by weekly visits for 4 weeks of observation for tolerance, side effects, and/or adverse reactions.

Device - Noxsano Bandage (Wound Care)

Wound care subjects will have weekly study device (Noxsano Bandage) applications to a specific ulceration. For subjects that exhibit any reduction in wound surface area, this application will occur until the wound is healed, or for up to 3 months (whichever occurs first). For subjects that do not exhibit any reduction in wound size at 2 months, application will stop and standard treatment protocols will be pursued. At the conclusion of the treatment window (up to 3 months), subjects will be foll ...read more on ClinicalTrials.org

Additional Information

Official Study Title

Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study

Clinical Trial ID

NCT04123093

ParticipAid ID

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