A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg 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 venous leg ulcers (VLU).

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcers
• 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 VLU 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 VLU (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 Contact: Name: Damon Keeley; Phone Number: 732-904-6590; Email: damon@prpconcepts.com

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 Proven venous disease 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 between and including the knee and the ankle Post-debridement, the ulcer size must be between 2 cm2 and 200 cm2 Demonstrated adequate compression 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:

Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, 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, or 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 Assignment
• 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; PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice; Other: Usual and Customary Practice; Usual and Customary Practice for non-healing venous leg ulcers; Other Names: Standard of Care
Other: Usual and Customary Practice; usual and customary practice	Other: Usual and Customary Practice; Usual and Customary Practice for non-healing venous leg ulcers; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete wound closure	Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks	12 weeks
Percent of wounds healed	Percent of wounds healed at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Health Survey	Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities	3 months
Wound Trajectory	Mean and 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 weeks visit.	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 8, 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; ulcer; venous stasis; non-healing wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: PC003

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