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 May 2015 by Arteriocyte, Inc.
Sponsor:
Information provided by (Responsible Party):
Arteriocyte, Inc.
ClinicalTrials.gov Identifier:
NCT02071979
First received: February 20, 2014
Last updated: May 29, 2015
Last verified: May 2015
  Purpose

This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the wound or surrounding tissue; or both; 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
Device: Autologous PRP Injections
Device: Autologous PRP Gel plus PRP Injections
Procedure: Standard Wound Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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)
Arms Assigned Interventions
Experimental: Autologous PRP Gel
The method of application for PRP treatment will be decided by the clinician in accordance with the appearance of the wound bed. The application of topical PRP gel may be used in chronic wounds possessing an open, moist wound bed according to following treatment schedule: 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 (Topical application) 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.
Procedure: Standard Wound Care
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
Experimental: Autologous PRP Injections
The method of application for PRP treatment will be decided by the clinician in accordance with the appearance of the wound bed. Autologous PRP Injections may be used where chronic wounds possess a raised, hyperproliferative wound margin and/or plaque, according to following treatment schedule: 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 Autologous PRP for injections. For data analysis, the data from these patients will be classified as PRP Treatment Group (Direct Injection) data.
Device: Autologous PRP Injections
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 drawn into multiple small syringes and injected directly into the wound bed or the skin surrounding it.
Procedure: Standard Wound Care
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
Experimental: Autologous PRP Gel plus PRP Injections
The method of application for PRP treatment will be decided by the clinician in accordance with the appearance of the wound bed. Some wounds may be suitable for both Autologous PRP Gel plus PRP Injections. Autologous PRP injections into, or to the periphery of, a moist wound bed in which no scarification or raised wound margin is apparent (where autologous PRP Gel can also be used) may further augment wound healing by addressing wound healing in multiple areas, following the treatment schedule: 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 (Topical and Direct) 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.
Device: Autologous PRP Injections
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 drawn into multiple small syringes and injected directly into the wound bed or the skin surrounding it.
Device: Autologous PRP Gel plus PRP Injections
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 PRP 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 divided into equal parts and half is drawn into multiple small syringes and injected directly into the skin surrounding the wound bed, half is activated (by mixing with thrombin and calcium chloride) and sprayed the wound bed.
Procedure: Standard Wound Care
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
No Intervention: Standard Wound Care
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices. For data analysis, the data from these patients will be classified as Control (Standard of Care) Group data

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, interventional, single-blinded, controlled, registry trial will be used. Data will be analyzed to compare patients who received PRP therapy (PRP gel application, PRP injection, or both) 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:

  1. Treatment of a chronic wound with standard of 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 (Control Group), which results in the patient's ability to return to previous function and resumption of normal activities.
  2. Treatment of a chronic wound with standard of 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 (Control Group).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medicare Eligible
  • Written informed consent obtained from either the subject or the subject'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/subject screening
  • DFU is 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 subject 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 subject should not be enrolled (screen failure).
  • The ulcer must be clinically non-infected
  • Able and willing to comply with the procedures required by the protocol. Subjects may be managed as either inpatient or outpatient.
  • If a female of childbearing potential, the subject must have a negative serum pregnancy test at screening.

Exclusion Criteria:

  • Subjects with known sensitivity to components of the Arteriocyte BioBandage™ (calcium chloride, thrombin, acid citrate dextrose solution A (ACDA)).
  • Current treatment of another chronic wound in the same limb.
  • Wound is not of DFU, PU, or VU 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) in the treatment limb.
  • Ulcer area decreases by greater than or equal to 30% during screening period
  • Subjects who are cognitively impaired and do not have a healthcare proxy.
  • Subject has inadequate venous access for repeated blood draw required for PRP preparation.
  • Subject has sickle cell anemia.
  • Subject 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. (Subjects must not have been enrolled in another clinical trial within 30 days prior to study entry and anytime during the course of the study).
  • Females who are nursing.
  • Subjects 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: Diane L. Orino, MA, CCRC 508-435-7412 dorino@arteriocyte.com
Contact: Christopher Rathbone, PhD crathbone@arteriocyte.com

Locations
United States, Maryland
Foot and Ankle Specialists of the Mid-Atlantic Recruiting
Kensington, Maryland, United States, 20895
Contact: Kyle Scholnick, DPM    301-949-2000    kscholnick@footandankle-use.com   
Principal Investigator: Kyle Scholnick, DPM         
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, North Carolina
Eastern Carolina Foot and Ankle Specialists Recruiting
Greenville, North Carolina, United States, 27834
Contact: Christy Lennon    252-830-1000    christylennon@embarqmail.com   
Principal Investigator: Christopher Gauland, DPM         
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 Recruiting
Beaver, Pennsylvania, United States, 15009
Contact: Thomas Michael, MD    724-770-7998    tmichael@hvhs.org   
Principal Investigator: Thomas Michael, MD         
Sponsors and Collaborators
Arteriocyte, Inc.
Investigators
Study Director: Christopher Rathbone, PhD Arteriocyte, 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: May 29, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2015