A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
NCT ID: NCT03078933
Last Updated: 2017-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-03-20
2018-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Standard of Care
Standard of care for diabetic foot ulcer wound care
Standard of Care
Standard of Care arm which includes wound care, dressings and debridement.
APT001NitricOxide tx 2x week 6 min+ SOC
APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care
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.
APT001Nitric Oxide tx 2x week 12 min+SOC
APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care
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.
APT001Nitric Oxide tx 4x week 6 min+SOC
APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care
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.
APT001Nitric Oxide tx 4x week 12 min+SOC
APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care
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.
Interventions
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Standard of Care
Standard of Care arm which includes wound care, dressings and debridement.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Active Charcot's disease
* wound involves deeper tissues including bone or tendon
* Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
22 Years
85 Years
ALL
No
Sponsors
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Origin Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Dantzker, MD
Role: STUDY_CHAIR
Origin Inc.
Terry Treadwell, MD
Role: PRINCIPAL_INVESTIGATOR
Institute for Advanced Wound Care
Locations
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Clinical Site
Montgomery, Alabama, United States
Clinical Site
Phoenix, Arizona, United States
Clinical Site
Tucson, Arizona, United States
Clinical Site
Fresno, California, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
San Francisco, California, United States
Clinical Site
Sylmar, California, United States
Clinical Site
Cooper City, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
West Columbia, South Carolina, United States
Clinical Site
Corpus Christi, Texas, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
Webster, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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ORI-16-003
Identifier Type: -
Identifier Source: org_study_id
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