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

Description

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 Start Date

February 2015

Estimated Completion Date

March 2016

Interventions

  • Device: SHAM
  • Device: APT001

Specialties

  • Internal Medicine: Vascular Medicine
  • Endocrinology: Diabetes
  • Physician Assistant: Endocrinology

MeSH Terms

  • Diabetic
  • Foot Ulcer,

Study ID

Advanced Plasma Therapies Inc -- APT-14-002

Status

Unknown

Trial ID

NCT02356835

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

80

Sponsor

Advanced Plasma Therapies Inc

Inclusion Criteria

  • Must be able to understand and adhere to all protocol procedures, return for all scheduled visits, and be willing and able to provide written informed consent.
  • Be able to be treated as an outpatient
  • Have an ABI ? 0.7
  • Have Type 1 or 2 diabetes with hemoglobin A1c < 12%
  • Have a full-thickness ulcer (one extending through the epidermis and the dermis) on the foot below the malleoli ? 1 cm2 and ? 30 cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)
  • Have only one infected ulcer on the foot
  • Have an ulcer either on the plantar aspect of the foot or toes or on the dorsum of the foot or toes but below the malleoli
  • Have a positive infection confirmed by punch biopsy with >105 organisms per gram of tissue
  • Have a local infection involving only the skin and the subcutaneous tissue (if erythema is present, it must be ? 2 cm around the ulcer).
  • Have no systemic inflammatory response

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

Gender

Both

Ages

19 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
New York College of Podiatric Medicine - New York, New York 46.1 miles Michael J Trepal DPM 212-410-8067 mtrepal@nycpm.edu
Gwinnett Medical Center - Lawrenceville, Georgia 773.5 miles None None None
Baptist Health Institute for Advanced Wound Care - Montgomery, Alabama 946.9 miles Terry A Treadwell MD 334-286-3444 None
Limb Preservation Platform Inc - Fresno, California 2,491.0 miles Vanessa Cazzell PhD 559-374-6644 vanessa@llpresearch.com
Limb Preservation Platform Inc - Fresno, California 2,495.1 miles Vanessa Cazzell PhD 559-374-6644 vanessa@llpresearch.com

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