search
Back to results

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

Primary Purpose

Venous Leg Ulcers

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRP Concepts Fibrin Bio-Matrix
Usual and Customary Practice
Sponsored by
PRP Concepts, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcers focused on measuring non-healing wounds, venous stasis, ulcer, platelet rich plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Westchester General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PRP Concepts Fibrin Bio-Matrix

Usual and Customary Practice

Arm Description

PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice

usual and customary practice

Outcomes

Primary Outcome Measures

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
Percent of wounds healed
Percent of wounds healed at 12 weeks

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2014
Last Updated
April 8, 2021
Sponsor
PRP Concepts, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02312518
Brief Title
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers
Official Title
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PRP Concepts, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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 venous leg ulcers (VLU).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
Keywords
non-healing wounds, venous stasis, ulcer, platelet rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP Concepts Fibrin Bio-Matrix
Arm Type
Experimental
Arm Description
PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Arm Title
Usual and Customary Practice
Arm Type
Other
Arm Description
usual and customary practice
Intervention Type
Device
Intervention Name(s)
PRP Concepts Fibrin Bio-Matrix
Intervention Description
PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Intervention Type
Other
Intervention Name(s)
Usual and Customary Practice
Other Intervention Name(s)
Standard of Care
Intervention Description
Usual and Customary Practice for non-healing venous leg ulcers
Primary Outcome Measure Information:
Title
Time to complete wound closure
Description
Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks
Time Frame
12 weeks
Title
Percent of wounds healed
Description
Percent of wounds healed at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wound Trajectory
Description
Mean and median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks
Time Frame
12 weeks
Title
Ulcer recurrence
Description
Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 weeks visit.
Time Frame
3 months
Title
Quality of Life Health Survey
Description
Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damon Keeley
Phone
732-904-6590
Email
damon@prpconcepts.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nigel Gladhart
Phone
415-378-7942
Email
nigel.gladhart@prpconcepts.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damon Keeley
Organizational Affiliation
PRP Concepts, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Westchester General Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose D Suarez, MD
Phone
305-264-5252
Ext
2200
Email
drjdsuarez@westchesterhospital.com
First Name & Middle Initial & Last Name & Degree
Gerardo Masferrer, MA, MS, PhD
Phone
305-264-5252
Ext
6200
Email
gerardo.masferrer@westchesterhospital.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs