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

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).

Study Overview

• Status: Recruiting
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: PRP Concepts Fibrin Bio-Matrix; Other: Usual and Customary Practice

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
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Recruiting
      • Westchester General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Standard of Care
OTHER: 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 Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound trajectory (Mean Change)	Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks	12 weeks
Wound trajectory (Median Change)	Median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks	12 weeks
Ulcer recurrence	Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit.	3 months
Quality of Life Health Survey	Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities	3 months

Collaborators and Investigators

• Sponsor: PRP Concepts, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (ESTIMATE): December 9, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: platelet rich plasma; pressure ulcer; non-healing wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: PC004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes