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NCT03078933 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

Official title:
A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03078933
Other study ID # ORI-16-003
Secondary ID
Status Recruiting
Phase N/A
First received February 28, 2017
Last updated June 5, 2017
Start date March 20, 2017
Est. completion date July 2018

Study information
Verified date June 2017
Source Origin Inc.
Contact Katherine M Tranotti, BSN/MBA
Phone 6092506000
Email ktranotti@originww.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 22 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
United States Clinical Site Boston Massachusetts
United States Clinical Site Cooper City Florida
United States Clinical Site Corpus Christi Texas
United States Clinical Site Fresno California
United States Clinical Site Los Angeles California
United States Clinical Site Miami Florida
United States Clinical Site Miami Florida
United States Clinical Site Montgomery Alabama
United States Clinical Site Phoenix Arizona
United States Clinical Site San Antonio Texas
United States Clinical Site San Francisco California
United States Clinical Site Sylmar California
United States Clinical Site Tucson Arizona
United States Clinical Site Webster Texas
United States Clinical Site West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Origin Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Closure rate cm2 of epithelium coverage per week 12 weeks of treatment
See also
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Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A