Safety and Efficacy of the Noxsano Wound Care Bandage

OhioHealth

Status: Terminated

Conditions: Ulcer, Leg; Peripheral Artery Disease; Wound Heal; Arterial Insufficiency; Diabetic Foot Ulcer; Ulcer Foot

Treatments: Device: Noxsano Bandage (Wound Care); Device: Noxsano Bandage (Healthy Volunteers)

Study type: Interventional

Funder types: Other

Identifiers

NCT04123093

1331496

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Healthy Volunteers

Experimental group

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.

Treatment:

Device: Noxsano Bandage (Healthy Volunteers)

Wound care

Experimental group

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.

Treatment:

Device: Noxsano Bandage (Wound Care)