Bone marrow aspirate versus platelet-rich fibrin for chronic plantar fasciitis

Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial

This compares injections of your own bone marrow aspirate versus platelet-rich fibrin to see which reduces heel pain and improves foot function in adults with chronic plantar fasciitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Federal University of São Paulo (Academic / other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT07242729 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind trial compares ultrasound-guided injections of autologous bone marrow aspirate (harvested from the posterior iliac crest) versus platelet-rich fibrin into the plantar fascia of patients with chronic plantar fasciitis. Procedures are performed under sterile conditions with regional tibial nerve anesthesia and ultrasound guidance to precisely target the symptomatic area. Participants are followed for pain (Visual Analog Scale), foot function (Modified AOFAS), and ultrasonographic plantar fascia thickness at multiple time points up to 24 months. Safety and adverse events are recorded throughout the follow-up period.

Who should consider this trial

Good fit: Adults 18–75 years old with ultrasound-confirmed chronic plantar fasciitis for more than six months, baseline VAS ≥4, and persistent symptoms despite conservative care are the intended participants.

Not a fit: Patients with prior surgery on the affected limb, active local infection or ulceration, systemic inflammatory disease, poorly controlled metabolic disorders, or current use of systemic corticosteroids, immunosuppressants, or anticoagulants are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, one of these orthobiologic injections could provide longer-lasting pain relief and better foot function for people who have not improved with standard conservative treatments.

How similar studies have performed: Smaller randomized trials and case series of platelet concentrates and bone marrow–derived products have shown promising reductions in pain and improved function, but head-to-head randomized comparisons between BMA and PRF are limited.

Eligibility criteria

Inclusion Criteria:

* Adults aged 18 to 75 years.
* Clinical diagnosis of chronic plantar fasciitis for more than 6 months, confirmed by ultrasonography (increased plantar fascia thickness and hypoechogenicity).
* Persistent heel pain refractory to conventional conservative treatment (stretching, orthotics, physical therapy, or corticosteroid injections).
* Visual Analog Scale (VAS) pain score ≥ 4 at baseline.
* Ability and willingness to comply with study procedures and follow-up assessments.
* Signed informed consent.

Exclusion Criteria:

* Previous foot or ankle surgery on the affected limb.
* Acute trauma, infection, or ulceration in the region of the plantar fascia.
* Systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, psoriatic arthritis).
* Metabolic or endocrine disorders interfering with healing (e.g., diabetes mellitus with poor glycemic control, thyroid disorders).
* Current use of systemic corticosteroids, immunosuppressants, or anticoagulants.
* Active neoplasia or hematologic disorders.
* Pregnancy or breastfeeding.
* Peripheral vascular disease or neuropathy affecting the lower limbs.
* Contraindications to local anesthesia or venipuncture.

Where this trial is running

São Paulo

• Federal University of São Paulo - Hospital São Paulo — São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Lucas Fonseca — Federal University of São Paulo
• Study coordinator: Lucas Fonseca, Md

Conditions Plantar Fasciitis; Bone Marrow Aspirate; Platelet-Rich Fibrin; Ultrasound-Guided Injection; Regenerative Medicine