Clinical trial NCT04123093: 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
Overall status: TERMINATED
Phase: NA
Conditions: Wound Heal
Peripheral Artery Disease
Ulcer, Leg
Ulcer Foot
Diabetic Foot Ulcer
Arterial Insufficiency
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: Noxsano, Inc.
First posted: 2019-10-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Adverse Events - Healthy Volunteers
timeFrame: 4 weeks post-bandage removal
measure: Wound Surface Area
timeFrame: change in baseline wound area at 2 months
Secondary outcomes:
measure: Adverse Events - Wound Care Subjects
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
Study officials:
affiliation: OhioHealth
name: Mitch Silver, DO
role: PRINCIPAL_INVESTIGATOR
References: