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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: contato@drlucasfonseca.med.br
• Phone: +5511982148662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.