Safety and Efficacy of the Noxsano Wound Care Bandage

Not Applicable

Terminated

• Conditions: Diabetic Foot Ulcer; Wound Heal; Peripheral Artery Disease; Ulcer, Leg; Ulcer Foot; Arterial Insufficiency
• Interventions: Device: Noxsano Bandage (Healthy Volunteers); Device: Noxsano Bandage (Wound Care)

• Registration Number: NCT04123093
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-09
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Results First Submitted: 2022-05-18
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Results First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Noxsano Bandage (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.
Wound care	Noxsano Bandage (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.

Primary Outcome Measures

Name	Time	Method
Adverse Events - Healthy Volunteers	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	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

Name	Time	Method
Adverse Events - Wound Care Subjects	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.

Trial Locations

Locations (1)

OhioHealth; 🇺🇸 Columbus, Ohio, United States