A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 13, 2021
April 1, 2021
12 months
December 5, 2014
April 8, 2021
Conditions
Keywords
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
Percentage of closure of the wound
12 weeks
Secondary Outcomes (3)
Wound Trajectory
4, 8, 12 weeks
Ulcer Recurrence
3 months
Quality of Life score
3 months
Study Arms (2)
PRP Concepts Fibrin Bio-Matrix
EXPERIMENTALPRP Concepts Fibrin Bio-Matrix
Usual and customary practice
ACTIVE COMPARATORUsual and customary practice
Interventions
Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Usual and customary care for non-healing wounds
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westchester General Hospital
Miami, Florida, 33155, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Damon Keeley
PRP Concepts, LLC
Central Study Contacts
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