Status:
UNKNOWN
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
Lead Sponsor:
PRP Concepts, LLC
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02312596
Start Date
January 1 2021
End Date
December 31 2021
Last Update
April 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Westchester General Hospital
Miami, Florida, United States, 33155