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
Qualifiers
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
Treatments tested in this trial
- Platelet-rich fibrin (PRF)
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Estar Medical dba Medical Technologies, LTD
Lead sponsor
Global Clinical Research Institute
Collaborator
Source ClinicalTrials.gov