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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Arteriocyte, Inc.
Sponsor:
Information provided by (Responsible Party):
Arteriocyte, Inc.
ClinicalTrials.gov Identifier:
NCT02071979
First received: February 20, 2014
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcers
Venous Ulcers
Pressure Ulcers
Device: Autologous PRP Gel

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Skin Wounds

Resource links provided by NLM:


Further study details as provided by Arteriocyte, Inc.:

Primary Outcome Measures:
  • Wound Size [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    Wound size will be measured with ruler/probe for length, width and depth as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.


Secondary Outcome Measures:
  • Rate of wound closure (change in wound size over time) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    The ratio of wound percent change over time will be used

  • Complete wound healing [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Complete wound healing is determined when the wound shows no sign of drainage for two consecutive visits (over two weeks)

  • Health Related Quality of Life [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    The Center for Disease Control (CDC) Health Related Quality of Life (HRQoL)-14, "Healthy Days Measure" will be administered

  • Wound recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Incidence of wound recurrence over the course of a year


Estimated Enrollment: 1500
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Autologous PRP Gel
Patients whose physicians choose to treat their chronic wound with Autologous PRP Gel will receive standard of care plus autologous PRP gel applied to their wound according to treatment strategy: Baseline/Week 0, Week 1, Week 2, Week 3, Week 7, and Week 11. The Arteriocyte Magellan® System (510(k) cleared) will be used to prepare the autologous PRP gel. For data analysis, the data from these patients will be classified as PRP Treatment Group data.
Device: Autologous PRP Gel
Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then activated (by mixing with thrombin and calcium chloride) and sprayed directly on the area to be treated.
Standard Wound Care
Patients whose physicians choose to treat their chronic wound according to accepted medical practice will receive standard wound care, only. For data analysis, the data from these patients will be classified as Standard Wound Care Group data.
Device: Autologous PRP Gel
Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then activated (by mixing with thrombin and calcium chloride) and sprayed directly on the area to be treated.

Detailed Description:

The proposed investigation is designed to solicit a large number of patients (N=1,500) with non-healing wounds (Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers) that have not responded to standard wound care in the previous 30 days or more. A prospective, observational, registry trial will be used. Data will be analyzed to compare patients who received PRP therapy and standard wound care (usual customary care) with patients who received standard wound care (usual customary care), only. Wound size, rate of healing, quality of life, and recurrence of wound will be measured during the 20-week period at usual office visits and at one-year post-enrollment, respectively.

Hypotheses to be tested:

  • Treatment of a chronic wound with standard wound care and autologous platelet rich plasma (PRP) will result in a reduction in wound size over a twenty-week period as compared to patients receiving standard wound care only (Case-matched cohort).
  • Treatment of a chronic wound with standard medical care and autologous platelet rich plasma (PRP) will increase the velocity of healing (rate of wound closure) over a twenty-week period as compared to patients receiving standard wound care only (Case-matched cohort).
  • Treatment of a chronic wound with standard medical care and autologous platelet rich plasma (PRP) will result in complete wound healing within twenty weeks, whereas complete wound healing will not be observed within twenty weeks in patients receiving standard wound care only (Case-matched cohort).
  • Treatment of a chronic wound with standard medical care and autologous platelet rich plasma (PRP) will improve quality of life scores as compared to patients receiving standard wound care only (Case-matched cohort). The Center for Disease Control (CDC) Health Related Quality of Life (HRQoL)-14 "Healthy Days Measure" will be administered to test this hypothesis.
  • Treatment of a chronic wound with standard wound care and autologous platelet rich plasma (PRP) will reduce incidence of wound recurrence as compared to patients receiving standard wound care only (Case-matched cohort).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participation will be offered to 1,500 male and female patients (N=1,500) over the age of 18 presenting with a non-healing skin wound that has persisted for at least 30 days. Only patients with Diabetic Foot Ulcers (DFU), Venous Ulcers (VU), or Pressure Ulcers (PU) will be included in the study.

Criteria

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/µL.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071979

Contacts
Contact: Maria L. Urso, PhD 508-435-7422 murso@arteriocyte.com

Locations
United States, Idaho
Sunnyside Foot and Ankle Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Cameron Bryan    208-529-2230    eips@cableone.net   
Principal Investigator: Tony Quentin, DPM         
United States, Maryland
Lea Medical Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Dallas Lea, DPM    301-495-3742      
Principal Investigator: Dallas Lea, DPM         
United States, New York
Comprehensive Wound Healing Center and Hyperbarics Recruiting
Lake Success, New York, United States, 11042
Contact: Sally Kaplan, RN       Skaplan2@nshs.edu   
Principal Investigator: Alisha Oropallo, M.D.         
United States, Ohio
Total Foot Care Recruiting
Cleveland, Ohio, United States, 44107
Contact: Rashelle Johnson    216-529-1800      
Principal Investigator: Jerome Lamendola, DPM         
United States, Pennsylvania
Heritage Valley Health System Not yet recruiting
Beaver, Pennsylvania, United States, 15009
Contact: Thomas Michael, MD    724-770-7998    tmichael@hvhs.org   
Principal Investigator: Thomas Michael, MD         
Wound Institute and Research Center Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: Michael Moore, M.D.    570-961-2000      
Principal Investigator: Michael Moore, M.D.         
Sponsors and Collaborators
Arteriocyte, Inc.
Investigators
Study Director: Maria L. Urso, PhD Arteriocyte Medical Systems, Inc.
  More Information

Publications:

Responsible Party: Arteriocyte, Inc.
ClinicalTrials.gov Identifier: NCT02071979     History of Changes
Other Study ID Numbers: ART-13-006, CAG-00190R3
Study First Received: February 20, 2014
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Arteriocyte, Inc.:
Chronic
Non-healing
Wounds

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pressure Ulcer
Varicose Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Varicose Veins

ClinicalTrials.gov processed this record on September 30, 2014