- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078933
A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine M Tranotti, BSN/MBA
- Phone Number: 6006 6092506000
- Email: ktranotti@originww.com
Study Contact Backup
- Name: Peter Pelka
- Phone Number: 6007 6092506000
- Email: ppelka@originww.com
Study Locations
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Alabama
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Montgomery, Alabama, United States, 36111
- Recruiting
- Clinical Site
-
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Arizona
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Phoenix, Arizona, United States, 85015
- Recruiting
- Clinical Site
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Tucson, Arizona, United States, 85634
- Recruiting
- Clinical Site
-
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California
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Fresno, California, United States, 93721
- Recruiting
- Clinical Site
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Los Angeles, California, United States, 90001
- Recruiting
- Clinical Site
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San Francisco, California, United States, 94115
- Recruiting
- Clinical Site
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Sylmar, California, United States, 91342
- Recruiting
- Clinical Site
-
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Florida
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Cooper City, Florida, United States, 33024
- Recruiting
- Clinical Site
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Miami, Florida, United States, 33031'
- Recruiting
- Clinical Site
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Miami, Florida, United States, 33032
- Recruiting
- Clinical Site
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Recruiting
- Clinical Site
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South Carolina
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West Columbia, South Carolina, United States, 29033
- Recruiting
- Clinical Site
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Texas
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Corpus Christi, Texas, United States, 78401
- Recruiting
- Clinical Site
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San Antonio, Texas, United States, 78229
- Recruiting
- Clinical Site
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Webster, Texas, United States, 78245
- Recruiting
- Clinical Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetes Type 1 or Type 2
- Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
- HbA1c less than or equal to 12 %
- Single full thickness DFU on the plantar aspect of toes or foot
- Ankle Brachial Index greater than or equal to 0.7
Exclusion Criteria:
- Infection of the ulcer
- Active Charcot's disease
- wound involves deeper tissues including bone or tendon
- Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
Standard of care for diabetic foot ulcer wound care
|
Standard of Care arm which includes wound care, dressings and debridement.
|
Experimental: APT001NitricOxide tx 2x week 6 min+ SOC
APT001 Nitric OxideTherapy 2x week for 6 min.
treatment time plus standard of care
|
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.
|
Experimental: APT001Nitric Oxide tx 2x week 12 min+SOC
APT001Nitric Oxide Therapy 2x week for 12 min.
treatment time plus standard of care
|
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.
|
Experimental: APT001Nitric Oxide tx 4x week 6 min+SOC
APT001 Nitric Oxide Therapy 4x week for 6 min.
treatment time plus standard of care
|
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.
|
Experimental: APT001Nitric Oxide tx 4x week 12 min+SOC
APT001Nitric Oxide Therapy 4x week for 12 min.
treatment time plus standard of care
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Closure rate
Time Frame: 12 weeks of treatment
|
cm2 of epithelium coverage per week
|
12 weeks of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Terry Treadwell, MD, Institute for Advanced Wound Care
- Study Chair: David Dantzker, MD, Origin Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- ORI-16-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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