Health TrialsbyHealthPanel

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

ConditionPlantar Fasciitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFederal University of São Paulo

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone Marrow Aspirate Injection

    Biological/Vaccine

    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 Injection

    Biological/Vaccine

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Bone Marrow Aspirate (BMA) GroupExperimental treatment 1 intervention
Group B: Platelet-Rich Fibrin (PRF) GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
baseline (0), 30 minutes, 1, 6, 12, and 24 months

Secondary outcomes

1

Change in Modified AOFAS Score

Improvement in the American Orthopaedic Foot and Ankle Society (AOFAS) score compared to baseline, reflecting pain and function.

Time frame
baseline, 1, 6, 12, 24 months
2

Change in Plantar Fascia Thickness by Ultrasound

Variation in plantar fascia thickness (in millimeters) evaluated by ultrasound before the procedure and at 12 months.

Time frame
Pre-procedure (baseline) and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal University of São Paulo

Lead sponsor

Source ClinicalTrials.gov
Apply now