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Safety and Efficacy of the Noxsano Wound Care Bandage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE August 9, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04123093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of the Noxsano Wound Care Bandage
Official Title  ICMJE Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Wound Heal
  • Peripheral Artery Disease
  • Ulcer, Leg
  • Ulcer Foot
  • Diabetic Foot Ulcer
  • Arterial Insufficiency
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Device: Noxsano Bandage (Healthy Volunteers)
  • 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.
    Intervention: Device: Noxsano Bandage (Wound Care)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Amanda Bliemeister, PhD, MSN, RN 614-566-1268 amanda.bliemeister@ohiohealth.com
Contact: Mitch Silver, DO 614-566-1250 mitch.silver@ohiohealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04123093
Other Study ID Numbers  ICMJE 1331496
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party OhioHealth
Study Sponsor  ICMJE OhioHealth
Collaborators  ICMJE Noxsano, Inc.
Investigators  ICMJE
Principal Investigator: Mitch Silver, DO OhioHealth
PRS Account OhioHealth
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP