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

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ClinicalTrials.gov Identifier: NCT02356835
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Origin Inc. ( Advanced Plasma Therapies Inc )

Brief 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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: APT001 Device: SHAM Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Percent change in total wound size [ Time Frame: Baseline to end of Week 10 ]
    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.


Secondary Outcome Measures :
  1. Change in bacterial load [ Time Frame: Baseline to end of Week 5 ]
    Clearance of wound infection based on clinical observation and wound biopsy cultures.

  2. Wound pain [ Time Frame: Baseline to end of Week 10 ]
    Wound pain measured by a standard wound pain scale completed at each visit prior to treatment or any study procedures.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356835


Locations
United States, Alabama
Baptist Health Institute for Advanced Wound Care
Montgomery, Alabama, United States, 36111
United States, California
Limb Preservation Platform, Inc.
Fresno, California, United States, 93720
Limb Preservation Platform, Inc.
Fresno, California, United States, 93721
United States, New York
New York College of Podiatric Medicine
New York, New York, United States, 10035
Sponsors and Collaborators
Advanced Plasma Therapies Inc
Investigators
Study Director: David R Dantzker, MD Advanced Plasma Therapies Inc
Principal Investigator: Terry A Treadwell, MD Institute for Advanced Wound Care Baptist Health

Responsible Party: Advanced Plasma Therapies Inc
ClinicalTrials.gov Identifier: NCT02356835     History of Changes
Other Study ID Numbers: APT-14-002
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents