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

NCT02312518 | Unknown FDA Device

• 1 other identifier: PC003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 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 venous leg ulcers (VLU).

Conditions

Venous Leg Ulcers

Keywords

non-healing wounds; venous stasis; ulcer; platelet rich plasma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Wound Trajectory

  12 weeks

• Ulcer recurrence

  3 months

• Quality of Life Health Survey

  3 months

Study Arms (2)

PRP Concepts Fibrin Bio-Matrix

EXPERIMENTAL

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

Device: PRP Concepts Fibrin Bio-Matrix; Other: Usual and Customary Practice

Usual and Customary Practice

OTHER

usual and customary practice

Other: Usual and Customary Practice

Interventions

PRP Concepts Fibrin Bio-Matrix DEVICE

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

PRP Concepts Fibrin Bio-Matrix

Usual and Customary Practice OTHER

Usual and Customary Practice for non-healing venous leg ulcers

Also known as: Standard of Care

PRP Concepts Fibrin Bio-Matrix; Usual and Customary Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PRP Concepts, LLC: lead

Study Sites (1)

Westchester General Hospital

Miami, Florida, 33155, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Damon Keeley

  PRP Concepts, LLC

  STUDY DIRECTOR

Central Study Contacts

Damon Keeley

CONTACT

732-904-6590; damon@prpconcepts.com

Nigel Gladhart

CONTACT

415-378-7942; nigel.gladhart@prpconcepts.com

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

Locations

US (1)