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APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults

NCT02356835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-03-17

No results posted yet for this study

Summary

This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

APT001

APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.

DEVICE

SHAM

Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

Sponsors & Collaborators

  • Origin Inc.

    lead INDUSTRY

Principal Investigators

  • David R Dantzker, MD · Origin Inc.

  • Terry A Treadwell, MD · Institute for Advanced Wound Care Baptist Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356835 on ClinicalTrials.gov