Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot 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 Diabetic Foot Ulcers.
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 DFU. 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.
Type I or II diabetes mellitus as determined by the physician / provider and undergoing therapy for glycemic control.
At randomization, the DFU must be assessable using the Wagner Scale Grades 1-5, specifically Grades 1 or 2 (full-thickness ulcer).
Disqualifiers
Ulcer is not medically diagnosed as DFU pathophysiology.
At randomization, the DFU is a zero on the Wagner Scale.
Presence of another wound within the boundaries of the target DFU; 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).
Trial design
Design model
Parallel
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.
Standard of Care (SoC)
Other interventionBeginning at the screening visit, participants will receive weekly treatment with Standard of Care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: PRFM + Standard of Care (SoC)Experimental treatment 1 intervention
Group B: Standard of Care (SoC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Between-arm difference in subjects that complete wound closure
The primary endpoint is complete (100%) wound closure after up to 20 weeks of PRFM + standard of care (SOC) versus SOC-alone.
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 between-arm difference in the frequency and nature of AEs in subjects receiving PRFM plus SoC versus SoC alone.
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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