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NCT Number: NCT07242729

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo - Hospital São Paulo

São Paulo, 04023-900, Brazil

Location status: Recruiting

Location contact

Lucas Fonseca, MD

CONTACT

[email protected]

+55 11 98214-8662

Lucas Fonseca, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BMA

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.

Other names: PRF

Primary outcomes

  1. Change in pain intensity (VAS) and occurrence of adverse events

    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.

Secondary outcomes

  1. Change in Modified AOFAS Score

    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.

  2. Change in Plantar Fascia Thickness by Ultrasound

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Franciozi, PhD

CONTACT

[email protected]

LUCAS FONSECA, MD

CONTACT

[email protected]

+5511982148662

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Acronym: fasciitis

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

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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