Arterial Insufficiency, Diabetic Foot Ulcer, Peripheral Artery Disease, Ulcer Foot, Ulcer, Leg, Wound Heal
Conditions
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.
Interventions
DEVICENoxsano 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.
DEVICENoxsano 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).
Sponsors
Noxsano, Inc.
OhioHealth
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
The study is designed to enroll into each arm sequentially. Therefore healthy subjects are enrolled first and once they have completed follow-up, wound care patients are eligible for enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Healthy volunteers with no skin wounds and who are not taking any prescription medications. | 10 |
| Wound Care Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency. | 2 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1 | Subject did not show up for baseline visit and was replaced | 1 | 0 |
| Phase 2 | Physician Decision | 0 | 1 |
| Phase 2 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Healthy Volunteers | Wound Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 0 Participants | 9 Participants |
| Age, Continuous | 39.9 years STANDARD_DEVIATION 13.4 | 69.5 years STANDARD_DEVIATION 0.5 | 44.8 years STANDARD_DEVIATION 16.5 |
| Body Mass Index | — | 29.8 kilograms pre meter squared STANDARD_DEVIATION 1 | 29.8 kilograms pre meter squared STANDARD_DEVIATION 1 |
| Concomitant Medications amlodipine | 0 participants | 1 participants | 1 participants |
| Concomitant Medications atorvastatin | 0 participants | 2 participants | 2 participants |
| Concomitant Medications clopidogrel | 0 participants | 1 participants | 1 participants |
| Concomitant Medications gabapentin | 0 participants | 1 participants | 1 participants |
| Concomitant Medications hydrochlorothiazide | 0 participants | 1 participants | 1 participants |
| Concomitant Medications hydrocodone -acetaminophen | 0 participants | 1 participants | 1 participants |
| Concomitant Medications lidocaine cream | 0 participants | 1 participants | 1 participants |
| Concomitant Medications lisinopril | 0 participants | 1 participants | 1 participants |
| Concomitant Medications losartan | 0 participants | 1 participants | 1 participants |
| Concomitant Medications metformin | 0 participants | 2 participants | 2 participants |
| Concomitant Medications metoprolol | 0 participants | 1 participants | 1 participants |
| Concomitant Medications potassium chloride SA | 0 participants | 1 participants | 1 participants |
| Concomitant Medications rivaroxaban | 0 participants | 1 participants | 1 participants |
| Concomitant Medications spironolactone | 0 participants | 1 participants | 1 participants |
| Concomitant Medications valsartan-hydrochlorothiazide | 0 participants | 1 participants | 1 participants |
| Concomitant Medications Vitamin C | 0 participants | 1 participants | 1 participants |
| Concomitant Medications Vitamin D3 | 0 participants | 1 participants | 1 participants |
| Height | — | 175.3 centimeters STANDARD_DEVIATION 5.1 | 175.3 centimeters STANDARD_DEVIATION 5.1 |
| Hemoglobin A1c | — | 7.8 mmol/mol STANDARD_DEVIATION 0.7 | 7.8 mmol/mol STANDARD_DEVIATION 0.7 |
| Medical History Diabetes | 0 participants | 2 participants | 2 participants |
| Medical History End Stage Renal Disease | 0 participants | 2 participants | 2 participants |
| Medical History Vascular Disease | 0 participants | 2 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United States | 10 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
| Smoking History Current Smoker | — | 0 participants | 0 participants |
| Smoking History Former Smoker | — | 1 participants | 1 participants |
| Smoking History Never Smoked | — | 1 participants | 1 participants |
| Weight | — | 82.1 kilograms STANDARD_DEVIATION 1.8 | 82.1 kilograms STANDARD_DEVIATION 1.8 |
| Wound Care Debridement | — | 2 participants | 2 participants |
| Wound Care Dermagraft | — | 1 participants | 1 participants |
| Wound Size | — | 8.98 centimeters squared | 8.98 centimeters squared |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 2 |
| other Total, other adverse events | 7 / 10 | 2 / 2 |
| serious Total, serious adverse events | 0 / 10 | 1 / 2 |
Outcome results
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.
Time frame: 4 weeks post-bandage removal
Population: Number of participants with an adverse event four weeks post bandage removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Volunteers | Adverse Events - Healthy Volunteers | 3 Participants |
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).
Time frame: change in baseline wound area at 2 months
Population: The study was not completed and data for this outcome were not collected
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.
Time frame: 12 months post-treatment
Population: The study was not completed and these data were not collected