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Trial record 3 of 55 for:    Recruiting, Not yet recruiting, Available Studies | "Pressure Ulcer"

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

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ClinicalTrials.gov Identifier: NCT02312570
Recruitment Status : Not yet recruiting
First Posted : December 9, 2014
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
PRP Concepts, LLC

Brief Summary:
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).

Condition or disease Intervention/treatment Phase
Pressure Ulcer 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 PU 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 PU (greater than 4 weeks 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.

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 Chronic Non-Healing Pressure Ulcers
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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

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

Usual and Customary Practice
Usual and customary practice for non-healing pressure wounds
Other: Usual and Customary Practice
Ussual and customary care of non-healing pressure 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 ]

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

  2. Wound trajectory (Median Change) [ Time Frame: 12 weeks ]
    Median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks

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

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



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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/Medicaid eligible Ulcer of pressure/shear etiology The index ulcer is greater than 4 weeks duration. Three or fewer ulcers that are separated by > 3.0 cm distance The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter Post-debridement, the ulcer size must be between 2 cm2 and 200 cm2 Demonstrated adequate offloading regimen Able and willing to attend scheduled follow-up visits and study related exams Able and willing to provide a voluntary written informed consent

Exclusion Criteria:

Stage I pressure ulcers Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology) Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis. Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA)) Serum albumin of less than 2.5 g/dL, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL Known renal failure as determined by a Creatinine > 2.5 mg/dl Malignancy at or near the ulcer site Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV Severe liver disease. 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, immunosuppressive therapy or chronic steroid use 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) Presence of another wound that is concurrently treated and might interfere with treatment of index wound Subjects who are cognitively impaired and do not have a healthcare proxy Life expectancy of < 6 months.


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): NCT02312570


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

Sponsors and Collaborators
PRP Concepts, LLC
Investigators
Study Director: Damon Keeley PRP Concepts, LLC

Responsible Party: PRP Concepts, LLC
ClinicalTrials.gov Identifier: NCT02312570     History of Changes
Other Study ID Numbers: PC004
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 wounds
pressure ulcer
platelet rich plasma

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases