Lower ExtremityPhase 1/2NCT07862335
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
A Phase 1/2 study testing PRFM in people with Lower Extremity and Chronic Ulcers, run by Tiger Biosciences, LLC..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU)
- What is being tested?
- PRFM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- The target ulcer has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4-weeks.
- Target wound has been deemed present for ≥ 1-month (4-weeks), and had a maximum of 52-weeks of SOC prior to the first study screening visit.
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- Post-debridement, subject's wound is free of necrotic debris and appears to be made up of healthy vascularized tissue.
- The target ulcer is free of clinical signs of infection, identified by inflammation (redness, warmth, swelling, tenderness, or pain) or purulent exudates (Lipsky et al, 2012).
- Subject has adequate perfusion to the impacted limb - as confirmed by vascular evaluation: ABI of ≥ 0.7 and ≤ 1.3, TBI ≥ 0.6, TCOM ≥ 40mmHg, PVR is biphasic.
- Subject must be able to read, speak, understand, and sign the Informed Consent Form.
- Female subjects must have a negative urine pregnancy test prior to the first treatment.
- Willing and able to adhere to the study protocol, plus treatment and follow-up schedule and pre/post-treatment care instructions.
- Willing to have photographs taken of the target wound and agree to the use of photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study.
Who cannot join
- 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.
- Serum Albumin of less than 2.5 g/dL.
- Plasma Platelet count of less than 100 x 109/L.
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- Inadequate amount of blood drawn to produce sufficient PRFM. One complete PRFM preparation requires 10ml of blood drawn.
- Target ulcer area decreases by ≥ 20% prior to and/or during 2-week screening/run-in period.
- Subject's target ulcer has tunnels or sinus tracts that cannot be completely debrided.
- Subject's target ulcer exposes tendon or bone.
- Subject has inadequate venous access for repeated blood draw required for centrifugation and completion of the treatment procedures.
- Subject has severe malnutrition as evidenced by mNA score <17 or albumin < 2.5 g/dL. A previous serum albumin test that is <6 weeks old is sufficient for this criteria.
- Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.
- Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation. Received topical steroids, systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived products for wounds during the 30 days preceding the screening visit; received radiation therapy or chemotherapy within previous 6 months.
- The target ulcer demonstrates underlying osteomyelitis, defined as infection in the bone, identified by fever, chills, or pain in the infected bone (for the purpose of the study, any exposed bone will be classified as osteomyelitis).
- Participant is expected to undergo a medical procedure for and/or around the target ulcer location during the study duration, includes any advanced wound care therapies or malignancy-related interventions in nearby wounds.
- Known to be sensitive to device components listed within the product IFU.
- Glycated hemoglobin (HbA1c) ≥ 12% within 3 months of the first study screening visit.
- History of malignant tumors in the target area.
- Pregnant and/or breastfeeding or planning to become pregnant during the study.
- Any medical condition that, in the opinion of the Investigator, would interfere with patient's participation in the full study protocol (e.g. gangrene, infections, frequent hospitalization, etc.).
- As per the Investigator's discretion, any physical or mental impairment which might make it unsafe for the subject to participate in this study. This includes subjects who are cognitively impaired and therefore cannot give consent, and do not have a healthcare proxy.
- Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
- History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-Center, Prospective, Open-label Study Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
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.
Read the detailed description
A multi-center, prospective, open-label study to 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.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU), Wound Management
- Being tested
- PRFM
- Keywords
- PRFM, PRP
- Medical subject headings
- Pressure Ulcer, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFMDevice
Participants will receive weekly applications of PRFM and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| PRFM + Standard of Care (SoC) | Experimental | Autologous Platelet-Rich Fibrin Plasma (PRFM) arm Receives: Device: PRFM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 to 20 weeks
Secondary outcomes (4)
Time to closure
Proportion of closed wounds in a defined treatment period
Measured: 1 to 20 weeks
Percent area reduction
Percent area reduction of the DFU from baseline
Measured: 1 to 20 weeks
W-QOL
Assessment for Quality of Life with Chronic Wounds
Measured: 1 to 20 weeks
Discomfort Assessment
To determine between-group differences in discomfort for patients
Measured: 1 to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-Center, Prospective, Open-Label
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiger Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862335
- Sponsor's protocol ID
- C-26-PRF02
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Open-label Study Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
- ClinicalTrials.gov ID
- NCT07862335
- Acronym / sponsor ID
- C-26-PRF02
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU), Wound Management
- Keywords
- PRFM, PRP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A multi-center, prospective, open-label study to 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-Center, Prospective, Open-Label
| Arm | Type | Receives |
|---|---|---|
| PRFM + Standard of Care (SoC) | Experimental | Device: PRFMAutologous Platelet-Rich Fibrin Plasma (PRFM) arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- The target ulcer has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4-weeks.
Key exclusion criteria (26 listed)
- 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.
- Serum Albumin of less than 2.5 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRFMParticipants will receive weekly applications of PRFM and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. | Device | PRFM + Standard of Care (SoC) |
Primary outcome
Prospective assessment of wound closure
Time frame: 1 to 20 weeks
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.
4 secondary outcomes
Time to closure
Time frame: 1 to 20 weeks
Percent area reduction
Time frame: 1 to 20 weeks
W-QOL
Time frame: 1 to 20 weeks
Discomfort Assessment
Time frame: 1 to 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRFM in people with Lower Extremity and Chronic Ulcers, run by Tiger Biosciences, LLC..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Director (1-888-665-5005, ArshdeepK@tigerbios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective assessment of wound closure (time frame: 1 to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.