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A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT03078933
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Origin Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Standard of Care Device: Nitric Oxide Therapy 2x week 6 min. plus standard of care Device: Nitric Oxide Therapy 2x week 12 min. plus standard of care Device: Nitric Oxide Therapy 4x week 6 min. plus standard of care Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
Masking: Single (Investigator)
Masking Description: Investigator will be blinded to photgraphs and punch biopsy results
Primary Purpose: Device Feasibility
Official Title: A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care
Standard of care for diabetic foot ulcer wound care
Device: Standard of 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
Device: Nitric Oxide Therapy 2x week 6 min. 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
Device: Nitric Oxide Therapy 2x week 12 min. 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
Device: Nitric Oxide Therapy 4x week 6 min. 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
Device: Nitric Oxide Therapy 4x week 12 min. 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.




Primary Outcome Measures :
  1. Wound Closure rate [ Time Frame: 12 weeks of treatment ]
    cm2 of epithelium coverage per week



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078933


Contacts
Contact: Katherine M Tranotti, BSN/MBA 6092506000 ext 6006 ktranotti@originww.com
Contact: Peter Pelka 6092506000 ext 6007 ppelka@originww.com

Locations
United States, Alabama
Clinical Site Recruiting
Montgomery, Alabama, United States, 36111
United States, Arizona
Clinical Site Recruiting
Phoenix, Arizona, United States, 85015
Clinical Site Recruiting
Tucson, Arizona, United States, 85634
United States, California
Clinical Site Recruiting
Fresno, California, United States, 93721
Clinical Site Recruiting
Los Angeles, California, United States, 90001
Clinical Site Recruiting
San Francisco, California, United States, 94115
Clinical Site Recruiting
Sylmar, California, United States, 91342
United States, Florida
Clinical Site Recruiting
Cooper City, Florida, United States, 33024
Clinical Site Recruiting
Miami, Florida, United States, 33031`
Clinical Site Recruiting
Miami, Florida, United States, 33032
United States, Massachusetts
Clinical Site Recruiting
Boston, Massachusetts, United States, 02118
United States, South Carolina
Clinical Site Recruiting
West Columbia, South Carolina, United States, 29033
United States, Texas
Clinical Site Recruiting
Corpus Christi, Texas, United States, 78401
Clinical Site Recruiting
San Antonio, Texas, United States, 78229
Clinical Site Recruiting
Webster, Texas, United States, 78245
Sponsors and Collaborators
Origin Inc.
Investigators
Study Chair: David Dantzker, MD Origin Inc.
Principal Investigator: Terry Treadwell, MD Institute for Advanced Wound Care

Responsible Party: Origin Inc.
ClinicalTrials.gov Identifier: NCT03078933     History of Changes
Other Study ID Numbers: ORI-16-003
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Origin Inc.:
DFU

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents