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

Status unconfirmed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT03078933

Run by

Origin Inc.

People needed

100

Starts

2017-03-20

Expected to finish

2018-07-01

Last updated by the study team

2017-06-07

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site — Montgomery, Alabama, United States (enrolling)
• Clinical Site — Phoenix, Arizona, United States (enrolling)
• Clinical Site — Tucson, Arizona, United States (enrolling)
• Clinical Site — Fresno, California, United States (enrolling)
• Clinical Site — Los Angeles, California, United States (enrolling)
• Clinical Site — San Francisco, California, United States (enrolling)
• Clinical Site — Sylmar, California, United States (enrolling)
• Clinical Site — Cooper City, Florida, United States (enrolling)
• Clinical Site — Miami, Florida, United States (enrolling)
• Clinical Site — Miami, Florida, United States (enrolling)
• Clinical Site — Boston, Massachusetts, United States (enrolling)
• Clinical Site — West Columbia, South Carolina, United States (enrolling)
• Clinical Site — Corpus Christi, Texas, United States (enrolling)
• Clinical Site — San Antonio, Texas, United States (enrolling)
• Clinical Site — Webster, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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