Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis (fasciitis)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Biological: Bone Marrow Aspirate Injection; Biological: Platelet-Rich Fibrin Injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LUCAS FONSECA, MD; Phone Number: +5511982148662; Email: contato@drlucasfonseca.med.br
• Study Contact Backup: Name: Carlos Franciozi, PhD; Email: cacarlos66@hotmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04023-900
    • Recruiting
    • Federal University of São Paulo - Hospital São Paulo
    • Contact: Lucas Fonseca, MD; Phone Number: +55 11 98214-8662; Email: contato@drlucasfonseca.med.br
    • Principal Investigator: Lucas Fonseca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone Marrow Aspirate (BMA) Group; Participants receive a single ultrasound-guided injection of autologous bone marrow aspirate (approximately 8 mL) into/around the plantar fascia on one side, according to randomization. Bone marrow aspirate is obtained from the posterosuperior iliac crest under local anesthesia and prepared under sterile conditions. The injection is performed after regional anesthesia of the tibial nerve using ultrasound guidance.	Biological: Bone Marrow Aspirate Injection; 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
Experimental: Platelet-Rich Fibrin (PRF) Group; Participants receive a single ultrasound-guided injection of autologous platelet-rich fibrin (PRF, approximately 8 mL) into/around the plantar fascia on the contralateral side, according to randomization. PRF is prepared from 60 mL of venous blood centrifuged without anticoagulant to form a fibrin clot, which is injected into the painful area of the fascia after regional anesthesia of the tibial nerve under ultrasound guidance.	Biological: Platelet-Rich Fibrin Injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity (VAS) and occurrence of adverse events	Pain intensity measured by Visual Analog Scale (VAS) and documentation of any adverse events, assessed at each time point by a blinded evaluator.	baseline (0), 30 minutes, 1, 6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified AOFAS Score	Improvement in the American Orthopaedic Foot and Ankle Society (AOFAS) score compared to baseline, reflecting pain and function.	baseline, 1, 6, 12, 24 months
Change in Plantar Fascia Thickness by Ultrasound	Variation in plantar fascia thickness (in millimeters) evaluated by ultrasound before the procedure and at 12 months.	Pre-procedure (baseline) and 12 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Lucas Fonseca, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Plantar Fasciitis; Bone Marrow Aspirate; Platelet-Rich Fibrin; Ultrasound-Guided Injection; Regenerative Medicine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: CAAE 90411925.0.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that support the findings of this study will be made available upon reasonable request after publication of the main results. Data will be shared with qualified researchers for academic purposes only, upon approval by the principal investigator and the ethics committee.
• IPD Sharing Time Frame: The IPD will be available beginning 6 months after publication and for up to 3 years thereafter.
• IPD Sharing Access Criteria: Researchers must provide a methodologically sound proposal and obtain approval from the study's principal investigator (Lucas Fonseca, MD). Data access will be granted through a secure data transfer agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No