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

NCT ID: NCT07242729

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-02-01

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.

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.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bone Marrow Aspirate Injection

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Platelet-Rich Fibrin Injection

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

BMA; PRF

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo de Almeida Mastrorosa

Principal Investigator / PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas Fonseca

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of São Paulo - Hospital São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

LUCAS FONSECA, MD

Role: CONTACT

contato@drlucasfonseca.med.br

+5511982148662

Carlos Franciozi, PhD

Role: CONTACT

cacarlos66@hotmail.com

Facility Contacts

Lucas Fonseca, MD

Role: primary

contato@drlucasfonseca.med.br

+55 11 98214-8662

Other Identifiers

CAAE 90411925.0.0000.5505

Identifier Type: -

Identifier Source: org_study_id