Safety and Efficacy of the Noxsano Wound Care Bandage

Diabetic Foot Ulcer Clinical Trial

Official title:

Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04123093
• Other study ID #: 1331496
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2019
• Est. completion date: September 9, 2020

Study information

• Verified date: December 2023
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Insufficiency
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Ulcer
• Ulcer Foot
• Ulcer, Leg
• Wound Heal
• Wounds and Injuries

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	OhioHealth	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	Noxsano, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events - Healthy Volunteers	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.	4 weeks post-bandage removal
Primary	Wound Surface Area	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).	change in baseline wound area at 2 months
Secondary	Adverse Events - Wound Care Subjects	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.	12 months post-treatment