Trial Outcomes & Findings for Safety and Efficacy of the Noxsano Wound Care Bandage (NCT NCT04123093)

Last Updated: 2023-12-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

4 weeks post-bandage removal

Results posted on

2023-12-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Healthy Volunteers Healthy volunteers with no skin wounds and who are not taking any prescription medications.	Wound Care Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency.
Phase 1 STARTED	11	0
Phase 1 Baseline Visit	10	0
Phase 1 COMPLETED	10	0
Phase 1 NOT COMPLETED	1	0
Phase 2 STARTED	0	2
Phase 2 Baseline Visit	0	2
Phase 2 COMPLETED	0	0
Phase 2 NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Volunteers Healthy volunteers with no skin wounds and who are not taking any prescription medications.	Wound Care Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency.
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

Body Mass Index (BMI) data was not collected for healthy volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=10 Participants Healthy volunteers with no skin wounds and who are not taking any prescription medications.	Wound Care n=2 Participants Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency.	Total n=12 Participants Total of all reporting groups
Region of Enrollment United States	10 Participants n=10 Participants	2 Participants n=2 Participants	12 Participants n=12 Participants
Age, Continuous	39.9 years STANDARD_DEVIATION 13.4 • n=10 Participants	69.5 years STANDARD_DEVIATION 0.5 • n=2 Participants	44.8 years STANDARD_DEVIATION 16.5 • n=12 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	1 Participants n=2 Participants	7 Participants n=12 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	1 Participants n=2 Participants	5 Participants n=12 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=2 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=2 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=2 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Black or African American	5 Participants n=10 Participants	1 Participants n=2 Participants	6 Participants n=12 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=2 Participants	0 Participants n=12 Participants
Race (NIH/OMB) White	5 Participants n=10 Participants	1 Participants n=2 Participants	6 Participants n=12 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=2 Participants	0 Participants n=12 Participants
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=2 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=10 Participants	0 Participants n=2 Participants	9 Participants n=12 Participants
Age, Categorical >=65 years	1 Participants n=10 Participants	2 Participants n=2 Participants	3 Participants n=12 Participants
Body Mass Index	—	29.8 kilograms pre meter squared STANDARD_DEVIATION 1.0 • n=2 Participants • Body Mass Index (BMI) data was not collected for healthy volunteers	29.8 kilograms pre meter squared STANDARD_DEVIATION 1.0 • n=2 Participants • Body Mass Index (BMI) data was not collected for healthy volunteers
Height	—	175.3 centimeters STANDARD_DEVIATION 5.1 • n=2 Participants • Height data was not collected for healthy volunteers	175.3 centimeters STANDARD_DEVIATION 5.1 • n=2 Participants • Height data was not collected for healthy volunteers
Hemoglobin A1c	—	7.8 mmol/mol STANDARD_DEVIATION 0.7 • n=2 Participants • Hemoglobin A1c measurements were not collected for health volunteers	7.8 mmol/mol STANDARD_DEVIATION 0.7 • n=2 Participants • Hemoglobin A1c measurements were not collected for health volunteers
Medical History Diabetes	0 participants n=10 Participants	2 participants n=2 Participants	2 participants n=12 Participants
Medical History Vascular Disease	0 participants n=10 Participants	2 participants n=2 Participants	2 participants n=12 Participants
Medical History End Stage Renal Disease	0 participants n=10 Participants	2 participants n=2 Participants	2 participants n=12 Participants
Concomitant Medications atorvastatin	0 participants n=10 Participants	2 participants n=2 Participants	2 participants n=12 Participants
Concomitant Medications amlodipine	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications clopidogrel	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications hydrocodone -acetaminophen	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications hydrochlorothiazide	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications gabapentin	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications lidocaine cream	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications lisinopril	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications losartan	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications metformin	0 participants n=10 Participants	2 participants n=2 Participants	2 participants n=12 Participants
Concomitant Medications metoprolol	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications rivaroxaban	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications valsartan-hydrochlorothiazide	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications potassium chloride SA	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications spironolactone	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications Vitamin C	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Concomitant Medications Vitamin D3	0 participants n=10 Participants	1 participants n=2 Participants	1 participants n=12 Participants
Smoking History Current Smoker	—	0 participants n=2 Participants • Smoking history data was not collected for healthy volunteers.	0 participants n=2 Participants • Smoking history data was not collected for healthy volunteers.
Smoking History Former Smoker	—	1 participants n=2 Participants • Smoking history data was not collected for healthy volunteers.	1 participants n=2 Participants • Smoking history data was not collected for healthy volunteers.
Smoking History Never Smoked	—	1 participants n=2 Participants • Smoking history data was not collected for healthy volunteers.	1 participants n=2 Participants • Smoking history data was not collected for healthy volunteers.
Weight	—	82.1 kilograms STANDARD_DEVIATION 1.8 • n=2 Participants • Weight was not collected for healthy volunteers	82.1 kilograms STANDARD_DEVIATION 1.8 • n=2 Participants • Weight was not collected for healthy volunteers
Wound Care Debridement	—	2 participants n=2 Participants • This measurement does not apply to healthy volunteers as they do not have skin wounds.	2 participants n=2 Participants • This measurement does not apply to healthy volunteers as they do not have skin wounds.
Wound Care Dermagraft	—	1 participants n=2 Participants • This measurement does not apply to healthy volunteers as they do not have skin wounds.	1 participants n=2 Participants • This measurement does not apply to healthy volunteers as they do not have skin wounds.
Wound Size	—	8.98 centimeters squared n=2 Participants • Wound size does not apply to healthy volunteers as they do not have wounds.	8.98 centimeters squared n=2 Participants • Wound size does not apply to healthy volunteers as they do not have wounds.

PRIMARY outcome

Timeframe: 4 weeks post-bandage removal

Population: Number of participants with an adverse event four weeks post bandage removal

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=10 Participants Healthy volunteers with no skin wounds and who are not taking any prescription medications.
Adverse Events - Healthy Volunteers	3 Participants

PRIMARY outcome

Timeframe: change in baseline wound area at 2 months

Population: The study was not completed and data for this outcome were not collected

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post-treatment

Population: The study was not completed and these data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Wound Care

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Healthy Volunteers n=10 participants at risk Healthy volunteers with no skin wounds and who are not taking any prescription medications.	Wound Care n=2 participants at risk Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency.
Skin and subcutaneous tissue disorders Pain	0.00% 0/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Number of events 1 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.

Other adverse events

Other adverse events
Measure	Healthy Volunteers n=10 participants at risk Healthy volunteers with no skin wounds and who are not taking any prescription medications.	Wound Care n=2 participants at risk Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency.
Skin and subcutaneous tissue disorders itchy skin	70.0% 7/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders dry dkin	50.0% 5/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders pain	20.0% 2/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders red skin	10.0% 1/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders swollen skin	20.0% 2/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders bruise	20.0% 2/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	0.00% 0/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders skin discoloration	50.0% 5/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	0.00% 0/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders skin flaking	10.0% 1/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	0.00% 0/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders skin darkening	0.00% 0/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Skin and subcutaneous tissue disorders pressure sores	0.00% 0/10 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.	50.0% 1/2 • Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants. A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.

Additional Information

Dr. Mitch Silver

OhioHealth

Phone: 614-566-1250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place