Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to Treat Chronic Non-Healing Wounds
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEstar Medical dba Medical Technologies, LTD
About this trial
Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. This will help determine the safety and effective use of PRF in the treatment of soft tissue defects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Male or female ≥ 18≤ 80 years of age 2. Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ulcer, pressure ulcer, or mechanically or surgically debrided.
Disqualifiers
Exclusion Criteria
Life expectancy is less than twelve (12) months.
Participation in another clinical trial involving an investigational device or drug within thirty (30) days prior to enrollment.
Sepsis within two (2) weeks prior to enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
Platelet-rich fibrin (PRF)
DeviceStandard of Care will include- 1. Nutritional Supplementation using 14 days Juven(R) 2. Wound Cleansing and Debridement 3. Mild to Moderate Compression as needed for edema Control 4. Off-loading as needed (foot gear, chair cushions, bed mattresses) 5. Antimicrobial Dressings as needed 6. Edema Control 7. Negative Pressure Wound Therapy- as needed 8. Collagen dressings as indicated 9. Optimized perfusion/oxygenation 10. Treated Underlying Medical Conditions
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Participants with non-infected, mild-to-moderate, chronic open soft tissue woundActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Complete Wound Closure
Number of Subjects with Complete Wound Closure- defined as 100% re-epithelialization remaining closed during two (2) consecutive weekly follow-up assessments. * Intent-to-treat analysis * Per-protocol analysis
Time frame
From Screening to end of follow-up at 9 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Estar Medical dba Medical Technologies, LTD
Lead sponsor
Global Clinical Research Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: