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

June 5, 2017 updated by: Origin Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36111
        • Recruiting
        • Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Recruiting
        • Clinical Site
      • Tucson, Arizona, United States, 85634
        • Recruiting
        • Clinical Site
    • California
      • Fresno, California, United States, 93721
        • Recruiting
        • Clinical Site
      • Los Angeles, California, United States, 90001
        • Recruiting
        • Clinical Site
      • San Francisco, California, United States, 94115
        • Recruiting
        • Clinical Site
      • Sylmar, California, United States, 91342
        • Recruiting
        • Clinical Site
    • Florida
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33031'
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33032
        • Recruiting
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Clinical Site
    • South Carolina
      • West Columbia, South Carolina, United States, 29033
        • Recruiting
        • Clinical Site
    • Texas
      • Corpus Christi, Texas, United States, 78401
        • Recruiting
        • Clinical Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Site
      • Webster, Texas, United States, 78245
        • Recruiting
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Origin Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terry Treadwell, MD, Institute for Advanced Wound Care
  • Study Chair: David Dantzker, MD, Origin Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORI-16-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings