Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTiger Biosciences, LLC.
About this trial
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female or Male, plus ≥18 years of age at the time the study Informed Consent is signed.
Proven and medically diagnosed chronic lower extremity ulcer. Subject's ulcer extends through the dermis and into subcutaneous tissue (granulation tissue may be present) but without exposure of muscle, tendon, bone or joint capsule.
For subjects with potentially multiple eligible lower extremity ulcers, the largest ulcer will be selected as the target ulcer for study. There must be at least 4 cm between the target ulcer and other ulcer(s).
The target wound surface area is between 1 cm2 (minimum) and 20 cm2 (maximum) post debridement by the study wound care provider.
Disqualifiers
Ulcer is not medically diagnosed as a lower extremity wound.
Presence of another wound within the boundaries of the target wound; especially if it is being concurrently treated and may interfere with the wound applicable for this study.
Presence of a clinically confirmed, infected wound, thereby requiring antibiotics. The presence of infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth, tenderness, pain, or induration) or purulent secretions (Lipsky et al, 2012).
Hemoglobin of less than 10.5 g/dL.
Trial design
Design model
Single group
Treatments tested in this trial
PRFM
DeviceParticipants will receive weekly applications of PRFM and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: PRFM + Standard of Care (SoC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prospective assessment of wound closure
Primary endpoint is the prospective assessment of wound closure after up to 20 weeks of application using PRFM in conjunction with standard of care (SOC) on chronic lower extremity wounds.
Time frame
1 to 20 weeksSecondary outcomes
1
Time to closure
Proportion of closed wounds in a defined treatment period
Time frame
1 to 20 weeks2
Percent area reduction
Percent area reduction of the DFU from baseline
Time frame
1 to 20 weeks3
W-QOL
Assessment for Quality of Life with Chronic Wounds
Time frame
1 to 20 weeks4
Discomfort Assessment
To determine between-group differences in discomfort for patients
Time frame
1 to 20 weeksOther outcomes
1
Adverse Events
To determine the frequency and nature of AEs in subjects receiving PRFM plus SoC.
Time frame
1 to 20 weeks2
SSQ
Subject satisfaction assessment to evaluate patient satisfaction with the application progression and outcome.
Time frame
1 to 20 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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