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A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT02312596
Recruitment Status : Recruiting
First Posted : December 9, 2014
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
PRP Concepts, LLC

Brief Summary:
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: PRP Concepts Fibrin Bio-Matrix Other: Usual and Customary Practice Phase 2 Phase 3

Detailed Description:
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRP Concepts Fibrin Bio-Matrix
PRP Concepts Fibrin Bio-Matrix
Device: PRP Concepts Fibrin Bio-Matrix
Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice

Other: Usual and Customary Practice
Usual and customary care for non-healing wounds
Other Name: Standard of Care

Active Comparator: Usual and customary practice
Usual and customary practice
Other: Usual and Customary Practice
Usual and customary care for non-healing wounds
Other Name: Standard of Care




Primary Outcome Measures :
  1. Time to complete wound closure [ Time Frame: 12 weeks ]
    Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks

  2. Percent of wounds healed [ Time Frame: 12 weeks ]
    Percentage of closure of the wound


Secondary Outcome Measures :
  1. Wound Trajectory [ Time Frame: 4, 8, 12 weeks ]
    Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks

  2. Ulcer Recurrence [ Time Frame: 3 months ]
    Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit.

  3. Quality of Life score [ Time Frame: 3 months ]
    Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medicare eligible
  • A full thickness diabetic foot ulcer with a viable wound bed
  • Diabetes mellitus (type I or II) that is adequately controlled
  • The ulcer is greater than 4 weeks duration.
  • The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel).
  • Post-debridement, the ulcer size must be between 0.5 - 20 cm2.
  • One of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle; or toe pressure of >40mm Hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
  • Able and willing to provide a voluntary written informed consent.
  • Able and willing to wear an off-loading device or orthopedic shoe
  • Able and willing to attend scheduled follow-up visits and study related exams

Exclusion Criteria:

  • Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator
  • Wagner 3, 4, 5 DFU
  • Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
  • Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates).
  • Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA))
  • Presence of Gangrene
  • Active Charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
  • Malignancy at or near the ulcer site
  • Known serum albumin < 2.5 mg/dl, Known renal failure as determined by a Creatinine > 2.5 mg/dl, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL
  • Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
  • Severe liver disease. Severe liver disease is defined as known history of chronic hepatitis or cirrhosis &/or the following abnormal Liver Function Tests: ALT & AST >35, ALP >120, PT >12 seconds.
  • Presence of additional abnormal lab values obtained within 7 days prior to the Day 0 visit determined to be clinically significant by the investigator including: WBC >13,000/cm3 or < 5, 000 cm3, or electrolytes that are outside the host institution's range of normal.
  • Radiation therapy, chemotherapy, chronic steroid use or immunosuppressive therapy within 30 days of enrollment
  • Received another investigational device or drug within 30 days of enrollment
  • Received allograft, autograft or xenograft within 30 days of enrollment
  • Subject has inadequate venous access for repeated blood draw required for Eclipse RPR administrations
  • Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.
  • Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)
  • Any condition judged by the investigator that would cause the study to be detrimental to the subject
  • Alcohol or drug abuse, defined as current medical treatment for substance abuse
  • Pregnant or nursing women

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): NCT02312596


Contacts
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Contact: Damon Keeley 732-530-2885 damon@prpconcepts.com

Locations
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United States, New Jersey
JCE Foot and Ankle Specialties Recruiting
Elizabeth, New Jersey, United States, 07202
Contact: Edwin R Roman, DPM    908-352-1400    drerrc1313@aol.com   
Sponsors and Collaborators
PRP Concepts, LLC
Investigators
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Study Director: Damon Keeley PRP Concepts, LLC

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Responsible Party: PRP Concepts, LLC
ClinicalTrials.gov Identifier: NCT02312596     History of Changes
Other Study ID Numbers: PC002
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PRP Concepts, LLC:
non-healing wound
diabetic foot ulcer
platelet rich plasma

Additional relevant MeSH terms:
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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