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

A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot 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 DFU 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 chronic Wagner grade 1 or 2 DFU (greater than 1 month 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 eligible
• A full thickness diabetic foot ulcer with a viable wound bed
• Diabetes mellitus (type I or II) that is adequately controlled
• The ulcer is greater than 4 weeks duration.
• The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel).
• Post-debridement, the ulcer size must be between 0.5 - 20 cm2.
• One of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle; or toe pressure of >40mm Hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
• Able and willing to provide a voluntary written informed consent.
• Able and willing to wear an off-loading device or orthopedic shoe
• Able and willing to attend scheduled follow-up visits and study related exams

Exclusion Criteria:

• Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator
• Wagner 3, 4, 5 DFU
• Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
• Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates).
• Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA))
• Presence of Gangrene
• Active Charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
• Malignancy at or near the ulcer site
• Known serum albumin < 2.5 mg/dl, Known renal failure as determined by a Creatinine > 2.5 mg/dl, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL
• Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
• Severe liver disease. Severe liver disease is defined as known history of chronic hepatitis or cirrhosis &/or the following abnormal Liver Function Tests: ALT & AST >35, ALP >120, PT >12 seconds.
• 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, chronic steroid use or immunosuppressive therapy 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)
• Any condition judged by the investigator that would cause the study to be detrimental to the subject
• Alcohol or drug abuse, defined as current medical treatment for substance abuse
• Pregnant or nursing women

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	Device: PRP Concepts Fibrin Bio-Matrix; Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice; Other: Usual and Customary Practice; Usual and customary care for non-healing wounds; Other Names: Standard of Care
Active Comparator: Usual and customary practice	Other: Usual and Customary Practice; Usual and customary care for non-healing wounds; 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	Percentage of closure of the wound	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Trajectory	Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks	4, 8, 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 score	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; diabetic foot ulcer; non-healing wound
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: PC002

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