Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers

NCT07840378 | Not Yet Recruiting Phase 1

• 1 other identifier: C-26-PRF01
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Foot Ulcer (DFU); Ulcer; Wound Closure; Wound Management

Keywords

PRFM; PRP; Diabetic Foot Ulcer

Outcome Measures

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.

  1 to 20 weeks

Secondary Outcomes (4)

• Time to closure

  1 to 20 weeks

• Percent area reduction

  1 to 20 weeks

• W-QOL

  1 to 20 weeks

• Discomfort Assessment

  1 to 20 weeks

Other Outcomes (2)

• Adverse Events

  1 to 20 weeks

• SSQ

  1 to 20 weeks

Study Arms (2)

PRFM + Standard of Care (SoC)

EXPERIMENTAL

Autologous Platelet-Rich Fibrin Plasma (PRFM) arm

Device: PRFM

Standard of Care (SoC)

ACTIVE COMPARATOR

SoC will be wound cleaning, wound debridement, and wound moisture balance.

Other: Standard of Care (SoC)

Interventions

PRFM DEVICE

Participants will receive weekly applications of PRFM and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

PRFM + Standard of Care (SoC)

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.

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Clinical Research Director

CONTACT

1-888-665-5005; ArshdeepK@tigerbios.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-Center, Prospective, Randomized Control

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09