Safety and Efficacy of the Noxsano Wound Care Bandage

NATerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

August 9, 2019

Primary Completion Date

September 9, 2020

Study Completion Date

September 9, 2020

Conditions
Wound HealPeripheral Artery DiseaseUlcer, LegUlcer FootDiabetic Foot UlcerArterial Insufficiency
Interventions
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 followed every 3 months for 12 consecutive months for observation of late side effects or adverse reactions (3 months of active treatment, 12 months of follow-up observation, 15 months total).

Trial Locations (1)

43214

OhioHealth, Columbus

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Noxsano, Inc.

INDUSTRY

lead

OhioHealth

OTHER

NCT04123093 - Safety and Efficacy of the Noxsano Wound Care Bandage | Biotech Hunter | Biotech Hunter