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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
Sponsor:
Collaborator:
Noxsano, Inc.
Information provided by (Responsible Party):
OhioHealth

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


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.
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).




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group 1: Subjects must meet all of the following criteria to be eligible for enrollment:

  1. Subject is ≥ 18 and < 80 years of age.
  2. Subject is white, black or African American
  3. Subject has provided written informed consent.
  4. Subject is willing to comply with study follow-up requirements.
  5. Subject has intact skin on lower extremities.

Group 2: Subjects must meet all of the following criteria to be eligible for enrollment:

  1. Subject is ≥ 18 and < 80 years of age.
  2. Subject has a baseline wound surface area of < 25 cm2.
  3. Subject has provided written informed consent.
  4. Subject is willing to comply with study follow-up requirements.
  5. Subject with at least one of the following:

    1. Diabetic lower extremity ulceration with a hemoglobin A1c (HgbA1c) value ≤ 9.0, drawn within 3 months prior to study participation , and/or
    2. 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
    3. 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:

  1. Subject is < 18 or ≥ 80 years of age.
  2. Subject has a history of diabetes, arterial insufficiency, or osteomyelitis.
  3. Subject has a known hypersensitivity to adhesives.
  4. 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.
  5. Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
  6. Subject is non-English speaking or reading.
  7. Subject is unable to give informed consent. -

Group 2: Subjects will be excluded from the trial if any of the following criteria are met:

  1. Subject is < 18 or ≥ 80 years of age.
  2. Subject has a baseline wound surface area of ≥ 25 cm2.
  3. Subject has a plantar wound.
  4. 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 .
  5. Subject with osteomyelitis contiguous with the ulceration treatment site.
  6. Subject with peripherally-inserted central catheter (PICC) line antibiotic treatment within the previous 6 months.
  7. Subject requiring any type of amputation on the treatment limb within 3 months prior to study participation.
  8. Subject with a known hypersensitivity to adhesives.
  9. Subject is on active steroid therapy (does not include inhaled steroids).
  10. Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
  11. Subject is non-English speaking or reading.
  12. Subject is unable to give informed consent.
  13. Subject is currently enrolled in another interventional study.

Information from the National Library of Medicine

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


Contacts
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Contact: Amanda Bliemeister, PhD, MSN, RN 614-566-1268 amanda.bliemeister@ohiohealth.com
Contact: Mitch Silver, DO 614-566-1250 mitch.silver@ohiohealth.com

Locations
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United States, Ohio
OhioHealth Recruiting
Columbus, Ohio, United States, 43214
Contact: Amanda Bliemeister, PhD    614-566-1250    amanda.bliemeister@ohiohealth.com   
Sponsors and Collaborators
OhioHealth
Noxsano, Inc.
Investigators
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Principal Investigator: Mitch Silver, DO OhioHealth

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Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT04123093     History of Changes
Other Study ID Numbers: 1331496
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Peripheral Arterial Disease
Foot Ulcer
Leg Ulcer
Ulcer
Wounds and Injuries
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases