NCT04123093

Safety and Efficacy of the Noxsano Wound Care Bandage

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Wound Heal
• Peripheral Artery Disease
• Ulcer, Leg
• Ulcer Foot
• Diabetic Foot Ulcer
• Arterial Insufficiency

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-08-09
• Primary completion: 2020-09-09
• Completion: 2020-09-09
• First posted: 2019-10-10
• Last updated: 2023-12-11
• Results posted: 2023-12-11

Locations

1 site across 1 country: United States