Federal University of São Paulo - Hospital São Paulo
São Paulo, 04023-900, Brazil
Location status: Recruiting
Location contact
Lucas Fonseca, MD
CONTACT
Lucas Fonseca, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07242729
This randomized, double-blind clinical trial aims to compare the clinical and imaging effects of autologous bone marrow aspirate versus platelet-rich fibrin injections in patients with chronic plantar fasciitis. The procedures are performed under ultrasound guidance to ensure precision and safety. The study evaluates pain reduction, foot function, and ultrasonographic changes in the plantar fascia at follow-up intervals.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
São Paulo, 04023-900, Brazil
Location status: Recruiting
Lucas Fonseca, MD
CONTACT
Lucas Fonseca, MD
PRINCIPAL_INVESTIGATOR
Chronic plantar fasciitis is a common cause of heel pain that may persist despite standard conservative measures such as physical therapy, stretching, orthoses, and corticosteroid injections. Regenerative medicine techniques, including autologous platelet concentrates and bone marrow-derived products, have emerged as potential alternatives to promote tissue healing and long-term symptom improvement.
This randomized controlled trial investigates and compares two minimally invasive orthobiologic interventions:
Bone Marrow Aspirate (BMA) - obtained from the posterior iliac crest under local anesthesia and injected into the most symptomatic region of the plantar fascia under ultrasound guidance.
Platelet-Rich Fibrin (PRF) - prepared from autologous venous blood by centrifugation without anticoagulants, forming a fibrin matrix injected into the plantar fascia under ultrasound guidance.
All procedures are performed under sterile conditions and tibial nerve regional anesthesia.
Pain and safety will be monitored using the Visual Analog Scale (VAS) and by recording adverse events at the following time points: baseline (0), 30 minutes, 1, 6, 12, and 24 months after the procedure.
Functional outcomes will be collected with Modified AOFAS Score at baseline, 1, 6, 12, and 24 months. Ultrasonography will measure plantar fascia thickness immediately before the intervention and at 12 months.
This research contributes to the growing evidence supporting orthobiologic therapies as viable, minimally invasive options for chronic plantar fasciitis management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided injection of autologous bone marrow aspirate obtained from the posterosuperior iliac crest under local anesthesia. Approximately 8mL of aspirate is injected into/around the plantar fascia.
Other names: BMA
Ultrasound-guided injection of autologous platelet-rich fibrin (PRF) prepared from 60 mL of venous blood centrifuged to form a fibrin clot. Approximately 8mL of PRF is injected into/around the plantar fascia.
Other names: PRF
Time frame: baseline (0), 30 minutes, 1, 6, 12, and 24 months
Pain intensity measured by Visual Analog Scale (VAS) and documentation of any adverse events, assessed at each time point by a blinded evaluator.
Time frame: baseline, 1, 6, 12, 24 months
Improvement in the American Orthopaedic Foot and Ankle Society (AOFAS) score compared to baseline, reflecting pain and function.
Time frame: Pre-procedure (baseline) and 12 months
Variation in plantar fascia thickness (in millimeters) evaluated by ultrasound before the procedure and at 12 months.
Contact information is provided by the study sponsor or research team.
Carlos Franciozi, PhD
CONTACT
LUCAS FONSECA, MD
CONTACT
Federal University of São Paulo
Other
Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial
Acronym: fasciitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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