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

Venous Leg Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02312518
• Other study ID #: PC003
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: PRP Concepts, LLC
• Contact: Damon Keeley
• Phone: 732-904-6590
• Email: damon[@]prpconcepts.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

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

Locations

Country	Name	City	State
United States	Westchester General Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
PRP Concepts, LLC

Country where clinical trial is conducted

United States, 

Outcome

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