Wound HealNCT04123093
Safety and Efficacy of the Noxsano Wound Care Bandage
A study testing Noxsano Bandage (Healthy Volunteers) and Noxsano Bandage (Wound Care) in people with Wound Heal and Peripheral Artery Disease, run by OhioHealth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Peripheral Artery Disease, Ulcer, Leg
- What is being tested?
- Noxsano Bandage (Healthy Volunteers) and Noxsano Bandage (Wound Care)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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.
- Subject requiring any type of amputation on the treatment limb within 3 months prior to study participation.
- Subject with a known hypersensitivity to adhesives.
- Subject is on active steroid therapy (does not include inhaled steroids).
- 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.
- Subject is currently enrolled in another interventional study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study
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
- Being tested
- Noxsano Bandage (Healthy Volunteers), Noxsano Bandage (Wound Care)
- Medical subject headings
- Peripheral Arterial Disease, Leg Ulcer, Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Noxsano Bandage (Wound Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: change in baseline wound area at 2 months
Secondary outcomes (1)
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.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start9 Aug 2019
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Why it stopped: Due to rigorous inclusion criteria and the constraints brought on the health care system from the COVID 19 pandemic which adversely effected enrollment, the sponsor and collaborator have decided to halt enrollment and officially close out the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Noxsano, Inc.
- Responsible party
- Sponsor
- Investigators
- Mitch Silver, DO, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123093
- Sponsor's protocol ID
- 1331496
- Status last verified
- Dec 2023
- First submitted
- 18 Sep 2019
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study
- ClinicalTrials.gov ID
- NCT04123093
- Acronym / sponsor ID
- 1331496
- Conditions
- Wound Heal, Peripheral Artery Disease, Ulcer, Leg, Ulcer Foot, Diabetic Foot Ulcer, Arterial Insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to rigorous inclusion criteria and the constraints brought on the health care system from the COVID 19 pandemic which adversely effected enrollment, the sponsor and collaborator have decided to halt enrollment and officially close out the study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- Noxsano, Inc.
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: 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 | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy Volunteers |
| 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). | Device | Wound care |
Primary outcome
Adverse Events - Healthy Volunteers
Time frame: 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
Time frame: 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).
1 secondary outcome
Adverse Events - Wound Care Subjects
Time frame: 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitch Silver, DO principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noxsano Bandage (Healthy Volunteers) and Noxsano Bandage (Wound Care) in people with Wound Heal and Peripheral Artery Disease, run by OhioHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events - Healthy Volunteers (time frame: 4 weeks post-bandage removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.