- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123093
Safety and Efficacy of the Noxsano Wound Care Bandage
Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43214
- OhioHealth
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Group 1: Subjects must meet all of the following criteria to be eligible for enrollment:
- Subject is ≥ 18 and < 80 years of age.
- Subject is white, black or African American
- Subject has provided written informed consent.
- Subject is willing to comply with study follow-up requirements.
- Subject has intact skin on lower extremities.
Group 2: Subjects must meet all of the following criteria to be eligible for enrollment:
- Subject is ≥ 18 and < 80 years of age.
- Subject has a baseline wound surface area of < 25 cm2.
- Subject has provided written informed consent.
- Subject is willing to comply with study follow-up requirements.
Subject with at least one of the following:
- Diabetic lower extremity ulceration with a hemoglobin A1c (HgbA1c) value ≤ 9.0, drawn within 3 months prior to study participation , and/or
- Arterial insufficiency lower extremity ulceration with a post-revascularization ankle-brachial index (ABI) value of ≥ 0.40 and ≤ 0.80 on the involved extremity, performed within 3 months prior to study participation1, and/or
- Diabetic and/or arterial insufficiency lower extremity ulceration deemed in-eligible for revascularization with 3 months prior to study participation
Exclusion Criteria:
Group 1: Subjects will be excluded from the trial if any of the following criteria are met:
- Subject is < 18 or ≥ 80 years of age.
- Subject has a history of diabetes, arterial insufficiency, or osteomyelitis.
- Subject has a known hypersensitivity to adhesives.
- Subject is on any prescription medications, including contraceptives. Due to the short duration of the procedure period (3 days), subjects who initiate prescription medications during study participation will continue in the study.
- Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
- Subject is non-English speaking or reading.
- Subject is unable to give informed consent. -
Group 2: Subjects will be excluded from the trial if any of the following criteria are met:
- Subject is < 18 or ≥ 80 years of age.
- Subject has a baseline wound surface area of ≥ 25 cm2.
- Subject has a plantar wound.
- Subject with diabetes with an HgbA1c value of > 9.0, drawn within 3 months prior to study participation . Subject with arterial insufficiency with an ABI value of < 0.40 or > 0.80, performed within 3 months prior to study participation .
- Subject with osteomyelitis contiguous with the ulceration treatment site.
- Subject with peripherally-inserted central catheter (PICC) line antibiotic treatment within the previous 6 months.
- Subject requiring any type of amputation on the treatment limb within 3 months prior to study participation.
- Subject with a known hypersensitivity to adhesives.
- Subject is on active steroid therapy (does not include inhaled steroids).
- Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
- Subject is non-English speaking or reading.
- Subject is unable to give informed consent.
- Subject is currently enrolled in another interventional study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events - Healthy Volunteers
Time Frame: 4 weeks post-bandage removal
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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.
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4 weeks post-bandage removal
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Wound Surface Area
Time Frame: change in baseline wound area at 2 months
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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).
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change in baseline wound area at 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events - Wound Care Subjects
Time Frame: 12 months post-treatment
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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.
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12 months post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mitch Silver, DO, OhioHealth
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Atherosclerosis
- Peripheral Vascular Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Peripheral Arterial Disease
- Wounds and Injuries
- Leg Ulcer
Other Study ID Numbers
- 1331496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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