Recruiting

PRP Concepts

Sponsor:

PRP Concepts, LLC

Code:

NCT02312596

Conditions

Diabetic Foot Ulcers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRP Concepts Fibrin Bio-Matrix

Usual and Customary Practice

Study Details

Brief summary:

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.

Conditions

Diabetic Foot Ulcers

Study ID

NCT02312596

Start date

Jan 1, 2021

Status verified date

Apr, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRP Concepts Fibrin Bio-Matrix

PRP Concepts Fibrin Bio-Matrix

active comparator: Usual and customary practice

Usual and customary practice

Interventions

PRP Concepts Fibrin Bio-Matrix

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

Usual and Customary Practice

Usual and customary care for non-healing wounds

Primary outcome measure

  • Time to complete wound closure [ Time Frame: 12 weeks ]
  • Percent of wounds healed [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Damon Keeley

732-530-2885damon@prpconcepts.com

Nigel Gladhart

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

Locations

Westchester General Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Jose D Suarez, MD

305-264-5252drjdsuarez@westchesterhospital.com

Gerardo Masferrer, MA, MS, PhD

305-264-5252gerardo.masferrer@westchesterhospital.com

More Information

Sponsor

PRP Concepts, LLC

Last update posted

Apr 13, 2021

Last verified

Apr, 2021

Keywords

  • non-healing wound
  • diabetic foot ulcer
  • platelet rich plasma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PRP Concepts, LLC on 2021-04-13.