Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds

Description

This study will examine differences in the process of wound-healing in patients treated with a gel made from platelet rich plasma (a concentration of proteins derived from a patients own blood) compared to patients treated with usual medical treatment . This study seeks to enroll patients who are 18 or older with a non-healing skin wound that is at least 30 days old. Only patients with Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.

Study Start Date

April 2014

Estimated Completion Date

December 2017

Interventions

  • Device: Autologous PRP Injections
  • Procedure: Standard Wound Care
  • Device: Autologous PRP Gel plus PRP Injections
  • Device: Autologous PRP Gel

Specialties

  • Surgery: Wound Healing
  • Endocrinology: Diabetes
  • Dermatology: Dermatopathology

MeSH Terms

  • Autologous PRP Gel
  • Diabetic Foot
  • Pressure Ulcer
  • Varicose Ulcer

Study ID

Arteriocyte, Inc. -- ART-13-006

Status

Unknown

Trial ID

NCT02071979

Study Type

Observational [Patient Registry]

Trial Phase

N/A

Enrollment Quota

1500

Sponsor

Arteriocyte, Inc.

Inclusion Criteria

  • Medicare Eligible
  • Written informed consent obtained from either the patient or the patient's legally acceptable representative prior to screening activities
  • Male or female ? 18 years of age
  • Duration of Diabetic Foot Ulcers (DFU),Venous Ulcers (VU), or Pressure Ulcers (PU) is greater than 30 days at first visit/patient screening
  • Classified as Wagner 1 -2 on the Wagner classification system
  • If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1
  • 2.
  • If a patient has multiple eligible wounds, the largest wound will be selected. There must be at least 4 cm between the index wound and other wounds
  • if all wounds are closer than 4 cm, the patient should not be enrolled (screen failure).
  • The ulcer must be clinically non-infected (culture assessment during patient eligibility screening)
  • Able and willing to comply with the procedures required by the protocol. Patients may be managed as either inpatient or outpatient.
  • If a female of childbearing potential, the patient must have a negative serum pregnancy test at screening.

Exclusion Criteria

  • Patients with known sensitivity to components of the Arteriocyte PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACDA)).
  • Current treatment of another chronic wound in the same limb.
  • Wound is not of DFU, Pressure ulcer or venostasis ulcer pathophysiology.
  • Presence of osteomyelitis, or if osteomyelitis is suspected.
  • Received systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived products for wounds during the 30 days preceding the screening visit.
  • Received radiation therapy or chemotherapy within previous 6 months.
  • Any malignancy other than non-melanoma skin cancer.
  • Patient has radiographic evidence consistent with diagnosis of neuropathic osteoarthropathy (Charcot foot).
  • Patients who are cognitively impaired and do not have a healthcare proxy.
  • Serum albumin of less than 2.5 g/dL.
  • Patient has inadequate venous access for repeated blood draw required for PRP preparation.
  • Patient has sickle cell anemia.
  • Patient is pregnant or plans to become pregnant during the duration of the trial.
  • Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study.
  • Concurrent participation in a clinical trial in which an investigational agent is used.
  • Females who are pregnant or nursing or intend to become pregnant during the duration of the study.
  • Patients with Thrombocytopenia < 100,000 platelets/┬ÁL.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Comprehensive Wound Healing Center and Hyperbarics - Lake Success, New York 39.6 miles None None None
Wound Care Center Englewood Hospital and Medical Center - Englewood, New Jersey 44.0 miles Neha Kalra 201-608-2107 NehaKalra@EHMCHealth.org
Heritage Valley Health System - Beaver, Pennsylvania 373.2 miles None None None
Total Foot Care - Cleveland, Ohio 444.4 miles None None None

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