Back to resultsSafety and Efficacy of the Noxsano Wound Care Bandage
Primary Purpose
Wound Heal, Peripheral Artery Disease, Ulcer, Leg
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noxsano Bandage (Healthy Volunteers)
Noxsano Bandage (Wound Care)
Sponsored by
About this trial
This is an interventional other trial for Wound Heal
Eligibility Criteria
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.
Sites / Locations
- OhioHealth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Volunteers
Wound care
Arm Description
The initial phase of the study is designed to determine the safety of the study device, the Noxsano Bandage, in healthy volunteers without wounds.
The second phase of the study is designed to determine the effectiveness of the study device in wound healing in subjects with active wounds.
Outcomes
Primary Outcome Measures
Adverse Events - Healthy Volunteers
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
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).
Secondary Outcome Measures
Adverse Events - Wound Care Subjects
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.
Full Information
NCT ID
NCT04123093
First Posted
September 18, 2019
Last Updated
May 2, 2022
Sponsor
OhioHealth
Collaborators
Noxsano, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04123093
Brief Title
Safety and Efficacy of the Noxsano Wound Care Bandage
Official Title
Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to rigorous inclusion criteria and the constraints brought on the health care system from the COVID 19 pandemic which adversely effected enrollment, the sponsor and collaborator have decided to halt enrollment and officially close out the study.
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
Collaborators
Noxsano, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Peripheral Artery Disease, Ulcer, Leg, Ulcer Foot, Diabetic Foot Ulcer, Arterial Insufficiency
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
The initial phase of the study is designed to determine the safety of the study device, the Noxsano Bandage, in healthy volunteers without wounds.
Arm Title
Wound care
Arm Type
Experimental
Arm Description
The second phase of the study is designed to determine the effectiveness of the study device in wound healing in subjects with active wounds.
Intervention Type
Device
Intervention Name(s)
Noxsano Bandage (Healthy Volunteers)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Noxsano Bandage (Wound Care)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adverse Events - Healthy Volunteers
Description
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.
Time Frame
4 weeks post-bandage removal
Title
Wound Surface Area
Description
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).
Time Frame
change in baseline wound area at 2 months
Secondary Outcome Measure Information:
Title
Adverse Events - Wound Care Subjects
Description
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.
Time Frame
12 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitch Silver, DO
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of the Noxsano Wound Care Bandage
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