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

NCT03078933 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-06-07

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Standard of Care

Standard of Care arm which includes wound care, dressings and debridement.

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.

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.

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.

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.

Sponsors & Collaborators

  • Origin Inc.

    lead INDUSTRY

Principal Investigators

  • David Dantzker, MD · Origin Inc.

  • Terry Treadwell, MD · Institute for Advanced Wound Care

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-05-31
Completion
2018-07-31
FDA Device
Yes

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 NCT03078933 on ClinicalTrials.gov