A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 13, 2021
April 1, 2021
12 months
December 5, 2014
April 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent of wounds that have healed at 12 weeks
To assess the efficacy and safety of an autologous PRP membrane matrix treatment by measurement and observation of time to and percent of complete wound closure, wound healing trajectory, and wound recurrence over time as compared to the standard of care non-healing wound treatment.
12 weeks
To assess by a validated interview-scoring tool, the changes in quality of life and ability to return to previous function/resumption of normal activities.
To assess by a validated interview-scoring tool, the changes in quality of life and ability to return to previous function/resumption of normal activities
12 weeks
Secondary Outcomes (4)
Wound trajectory (Mean Change)
12 weeks
Wound trajectory (Median Change)
12 weeks
Ulcer recurrence
3 months
Quality of Life Health Survey
3 months
Study Arms (2)
PRP Concepts Fibrin Bio-Matrix
EXPERIMENTALPRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Usual and Customary Practice
OTHERUsual and customary practice for non-healing pressure wounds
Interventions
Administration of PRP Concepts Fibrin Bio-Matrix to wound in addition to usual and customary care
Ussual and customary care of non-healing pressure wounds
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westchester General Hospital
Miami, Florida, 33155, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Damon Keeley
PRP Concepts, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 9, 2014
Study Start
January 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
April 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share