Safety and Efficacy of the Noxsano Wound Care Bandage
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|ClinicalTrials.gov Identifier: NCT04123093|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Wound Heal Peripheral Artery Disease Ulcer, Leg Ulcer Foot Diabetic Foot Ulcer Arterial Insufficiency||Device: Noxsano Bandage (Healthy Volunteers) Device: Noxsano Bandage (Wound Care)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study has two interventions: (1) Noxsano Bandage (Healthy Volunteers) and (2) Noxsano Bandage (Wound Care). Each intervention is associated with a separate group of participants.|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Healthy Volunteers
The initial phase of the study is designed to determine the safety of the study device, the Noxsano Bandage, in healthy volunteers without wounds.
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.
Experimental: Wound care
The second phase of the study is designed to determine the effectiveness of the study device in wound healing in subjects with active wounds.
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).
- Adverse Events - Healthy Volunteers [ Time Frame: 4 weeks post-bandage removal ]Adverse events related to the Noxsano bandage will be assessed using a safety and adverse reactions questionnaire that includes questions for the subject regarding tolerance, side effects, and adverse events.
- Wound Surface Area [ Time Frame: change in baseline wound area at 2 months ]Wound surface area will be measured using a horizontal and vertical measurement taken in centimeters (cm) using a standard ruler. These measurements are used to calculate wound area in centimeters squared (cm2).
- Adverse Events - Wound Care Subjects [ Time Frame: 12 months post-treatment ]Adverse events related to the Noxsano bandage will be assessed using a safety and adverse reactions questionnaire that includes questions for the subject regarding tolerance, side effects, and adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123093
|Contact: Amanda Bliemeister, PhD, MSN, RNfirstname.lastname@example.org|
|Contact: Mitch Silver, DOemail@example.com|
|United States, Ohio|
|Columbus, Ohio, United States, 43214|
|Contact: Amanda Bliemeister, PhD 614-566-1250 firstname.lastname@example.org|
|Principal Investigator:||Mitch Silver, DO||OhioHealth|