Safety and Efficacy of the Noxsano Wound Care Bandage

NCT04123093 | Terminated Results

• 1 other identifier: 1331496
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Adverse Events - Wound Care Subjects

  12 months post-treatment

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

The initial phase of the study is designed to determine the safety of the study device, the Noxsano Bandage, in healthy volunteers without wounds.

Device: Noxsano Bandage (Healthy Volunteers)

Wound care

EXPERIMENTAL

The second phase of the study is designed to determine the effectiveness of the study device in wound healing in subjects with active wounds.

Device: Noxsano Bandage (Wound Care)

Interventions

Noxsano Bandage (Healthy Volunteers) DEVICE

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.

Healthy Volunteers

Noxsano Bandage (Wound Care) DEVICE

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).

Wound care

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1: Subjects must meet all of the following criteria to be eligible for enrollment:
• Subject is ≥ 18 and \< 80 years of age.
• Subject is white, black or African American
• Subject has provided written informed consent.
• Subject is willing to comply with study follow-up requirements.
• Subject has intact skin on lower extremities.
• Group 2: Subjects must meet all of the following criteria to be eligible for enrollment:
• Subject is ≥ 18 and \< 80 years of age.
• Subject has a baseline wound surface area of \< 25 cm2.
• Subject has provided written informed consent.
• Subject is willing to comply with study follow-up requirements.
• Subject with at least one of the following:
• Diabetic lower extremity ulceration with a hemoglobin A1c (HgbA1c) value ≤ 9.0, drawn within 3 months prior to study participation , and/or
• 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
• Diabetic and/or arterial insufficiency lower extremity ulceration deemed in-eligible for revascularization with 3 months prior to study participation

You may not qualify if:

• Group 1: Subjects will be excluded from the trial if any of the following criteria are met:
• Subject is \< 18 or ≥ 80 years of age.
• Subject has a history of diabetes, arterial insufficiency, or osteomyelitis.
• Subject has a known hypersensitivity to adhesives.
• 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.
• Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
• Subject is non-English speaking or reading.
• Subject is unable to give informed consent. -
• Group 2: Subjects will be excluded from the trial if any of the following criteria are met:
• Subject is \< 18 or ≥ 80 years of age.
• Subject has a baseline wound surface area of ≥ 25 cm2.
• Subject has a plantar wound.
• 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 .
• Subject with osteomyelitis contiguous with the ulceration treatment site.
• Subject with peripherally-inserted central catheter (PICC) line antibiotic treatment within the previous 6 months.

Sponsors & Collaborators

• OhioHealth: lead
• Noxsano, Inc.: collaborator

Study Sites (1)

OhioHealth

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Leg Ulcer; Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Dr. Mitch Silver
• Organization: OhioHealth

mitch.silver@ohiohealth.com

614-566-1250

Study Officials

• Mitch Silver, DO

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 10, 2019
• Study Start: August 9, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)