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The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing.
The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.
APT001 is a medical device that generates nitric oxide (NO) from ambient room air within a defined plasma stream. This study is a randomized, prospective, multi-center feasibility study that will assess the effect of Nitric Oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (DFUs) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the APT001 device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of care for diabetic foot ulcer wound care |
|
| APT001NitricOxide tx 2x week 6 min+ SOC | Experimental | APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care |
|
| APT001Nitric Oxide tx 2x week 12 min+SOC | Experimental | APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care |
|
| APT001Nitric Oxide tx 4x week 6 min+SOC | Experimental | APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care |
|
| APT001Nitric Oxide tx 4x week 12 min+SOC | Experimental | APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Device | Standard of Care arm which includes wound care, dressings and debridement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure rate | cm2 of epithelium coverage per week | 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine M Tranotti, BSN/MBA | Contact | 6092506000 | 6006 | ktranotti@originww.com |
| Peter Pelka | Contact | 6092506000 | 6007 | ppelka@originww.com |
| Name | Affiliation | Role |
|---|---|---|
| David Dantzker, MD | Origin Inc. | Study Chair |
| Terry Treadwell, MD | Institute for Advanced Wound Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Recruiting | Montgomery | Alabama | 36111 | United States | |
| Clinical Site |
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Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
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Investigator will be blinded to photgraphs and punch biopsy results
| Nitric Oxide Therapy 2x week 6 min. plus standard of care | Device | Active Therapy Nitric Oxide delivered topically to the wound twice a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. |
|
| Nitric Oxide Therapy 2x week 12 min. plus standard of care | Device | Active Therapy Nitric Oxide delivered topically to the wound twice a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. |
|
| Nitric Oxide Therapy 4x week 6 min. plus standard of care | Device | Active Therapy Nitric Oxide delivered topically to the wound four times a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. |
|
| Nitric Oxide Therapy 4x week 12 min. plus standard of care | Device | Active Therapy Nitric Oxide delivered topically to the wound four times a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. |
|
| Recruiting |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Clinical Site | Recruiting | Tucson | Arizona | 85634 | United States |
| Clinical Site | Recruiting | Fresno | California | 93721 | United States |
| Clinical Site | Recruiting | Los Angeles | California | 90001 | United States |
| Clinical Site | Recruiting | San Francisco | California | 94115 | United States |
| Clinical Site | Recruiting | Sylmar | California | 91342 | United States |
| Clinical Site | Recruiting | Cooper City | Florida | 33024 | United States |
| Clinical Site | Recruiting | Miami | Florida | 33031' | United States |
| Clinical Site | Recruiting | Miami | Florida | 33032 | United States |
| Clinical Site | Recruiting | Boston | Massachusetts | 02118 | United States |
| Clinical Site | Recruiting | West Columbia | South Carolina | 29033 | United States |
| Clinical Site | Recruiting | Corpus Christi | Texas | 78401 | United States |
| Clinical Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Clinical Site | Recruiting | Webster | Texas | 78245 | United States |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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