APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults (APT-14-002)

A Pivotal Study of the Use of Nitric Oxide / Plasma Therapy as Produced by the APT001 Plasma / Nitric Oxide Generator in Adult Subjects With a Diabetic Foot Ulcer

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.

Study Overview

• Status: Completed
• Conditions: Foot Ulcer, Diabetic
• Intervention / Treatment: Device: APT001; Device: SHAM

Detailed Description

Approximately 80 subjects will be randomized by computer to receive equally either sham therapy or plasma / nitric oxide treatments topically. The nitric oxide / plasma treatment will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2 of wound size. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations. The wounds of both groups will be treated with sharp debridement as determined by the site Investigator. A collagen dressing, a non-adherent dressing, and an absorptive dressing will be applied to the wound after either the study therapy or the sham therapy.

For an initial safety evaluation in patients with DFU, the first ten patients randomized will be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after each treatment session. Following completion of the final assessment in these 10 patients, data will be submitted to FDA for review and approval before opening the enrolment for the remaining patients.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36111
      • Baptist Health Institute for Advanced Wound Care
  • California
    • Fresno, California, United States, 93721
      • Limb Preservation Platform, INC.
    • Fresno, California, United States, 93720
      • Limb Preservation Platform, INC.
  • New York
    • New York, New York, United States, 10035
      • New York College of Podiatric Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 19 to 80 years of age
• Type 1 or 2 diabetes with hemoglobin A1c less than 12%
• ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
• Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)

Exclusion Criteria:

• Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
• Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending > 2 cm beyond the ulcer margin, or osteomyelitis
• Have involvement of deeper tissues including bone or tendon
• Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
• Have received topical or systemic antimicrobial therapy within 48 hours of screening
• Have a malignancy other than skin cancer currently being treated
• Have substance abuse issues within the 6 months prior to screening
• Is a woman who is pregnant or breast feeding
• Has been treated with another investigational product within 30 days of screening
• Has been treated with tissue engineered skin or a biological therapy within 30 days of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: APT001; The APT001 is a medical device that generates a plasma flow containing nitric oxide intended to be applied topically to wound sites. The nitric oxide / plasma flow will be directed at the wound site and surrounding skin at a distance of 11.5 to 15 centimeters from the skin surface. Dose will be 10 seconds / cm2 wound surface area. Administration of the therapy will include a 2 cm border around the defined edges of the wound site.	Device: APT001; APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.; Other Names: APT001 Plasma/Nitric Oxide
SHAM_COMPARATOR: SHAM; Treatment with a sham device to deliver non-medicated, heated room air to the wound in the same manner and dose as the active treatment device.	Device: SHAM; Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in total wound size	Change in total wound size using dimensional measurements of the wound and using the Aranz SilhouetteStar + SilhouetteConnect wound assessment device from Baseline to Week 10.	Baseline to end of Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bacterial load	Clearance of wound infection based on clinical observation and wound biopsy cultures.	Baseline to end of Week 5
Wound pain	Wound pain measured by a standard wound pain scale completed at each visit prior to treatment or any study procedures.	Baseline to end of Week 10

Collaborators and Investigators

• Sponsor: Origin Inc.
• Investigators: Study Director: David R Dantzker, MD, Origin Inc.; Principal Investigator: Terry A Treadwell, MD, Institute for Advanced Wound Care Baptist Health

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (ESTIMATE): February 5, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: APT-14-002