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

NCT07242729 | Recruiting

• 1 other identifier: CAAE 90411925.0.0000.5505
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fasciitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Modified AOFAS Score

  baseline, 1, 6, 12, 24 months

• Change in Plantar Fascia Thickness by Ultrasound

  Pre-procedure (baseline) and 12 months

Study Arms (2)

Bone Marrow Aspirate (BMA) Group

EXPERIMENTAL

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

Platelet-Rich Fibrin (PRF) Group

EXPERIMENTAL

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

Interventions

Bone Marrow Aspirate Injection BIOLOGICAL

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.

Also known as: BMA

Bone Marrow Aspirate (BMA) Group

Platelet-Rich Fibrin Injection BIOLOGICAL

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.

Also known as: PRF

Platelet-Rich Fibrin (PRF) Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo - Hospital São Paulo

São Paulo, 04023-900, Brazil

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Lucas Fonseca

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUCAS FONSECA, MD

CONTACT

+5511982148662; contato@drlucasfonseca.med.br

Carlos Franciozi, PhD

CONTACT

cacarlos66@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind design: both participants and investigators performing follow-up assessments are blinded to group allocation. The injectate is prepared in a separate room by a technician not involved in patient assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / PhD Candidate

Model Details: Two-arm, parallel, randomized, controlled clinical trial comparing the effects of ultrasound-guided injection of Bone Marrow Aspirate versus Platelet-Rich Fibrin in patients with chronic plantar fasciitis.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IPD will be available beginning 6 months after publication and for up to 3 years thereafter.
• 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.

Locations

BR (1)