Diabetic Foot Ulcer (DFU)Phase 1/2NCT07840378
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers
A Phase 1/2 study testing PRFM in people with Diabetic Foot Ulcer (DFU) and Ulcer, 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 Diabetic Foot Ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Ulcer, Wound Closure
- What is being tested?
- PRFM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2027
- Phase
- Phase 1/2
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 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).
- The DFU is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces).
- For subjects with potentially multiple eligible DFUs, the ulcer which best fits the study criteria will be selected as the 'target ulcer' for study. There must be at least 4 cm between the target ulcer and other ulcers.
Show all 18Show fewer
- At randomization, the target DFU surface area is between 1 cm2 (minimum) and 50 cm2 (maximum) post debridement by the study wound care provider.
- The target DFU has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4-weeks.
- Target DFU 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.
- Demonstrated adequate offloading regime. Patients require 4 weeks of documented offloading prior to enrollment in the trial.
- 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 circulation to the study foot as evidenced by an ankle-brachial index (ABI) of ≥ 0.65-1.30 after 10 minutes of rest.
- 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 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).
- Hemoglobin of less than 10.5 g/dL.
- Serum Albumin of less than 2.5 g/dL.
Show all 29Show fewer
- Plasma Platelet count of less than 100 x 109/L.
- 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 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.
- Subject has radiographic evidence consistent with diagnosis of active Charcot foot. Untreated Charcot foot or DFUs associated with a treated Charcot deformity in which reconstruction or offloading has not taken place.
- No history of Type I or II diabetes mellitus.
- Known to be sensitive to device components listed within the IFU.
- The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- 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, Randomized, Safety and Efficacy Study Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot 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 Diabetic Foot Ulcers.
Read the detailed description
A multi-center, prospective, randomized 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 Diabetic Foot Ulcers.
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer, Wound Closure, Wound Management
- Being tested
- PRFM, Standard of Care (SoC)
- Keywords
- PRFM, PRP, Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot, 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.
Standard of Care (SoC)Other
Beginning 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.
| Study group | Role | What they receive |
|---|---|---|
| PRFM + Standard of Care (SoC) | Experimental | Autologous Platelet-Rich Fibrin Plasma (PRFM) arm Receives: Device: PRFM |
| Standard of Care (SoC) | Active comparator | SoC will be wound cleaning, wound debridement, and wound moisture balance. Receives: Other: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted25 Sep 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 Diabetic Foot Ulcer (DFU)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-Center, Prospective, Randomized Control
- Masking
- None (open label)
- Enrolment
- 55 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
- NCT07840378
- Sponsor's protocol ID
- C-26-PRF01
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No