Actively Recruiting
Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial
Led by Federal University of São Paulo · Updated on 2025-11-21
72
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different injections for treating chronic plantar fasciitis, a common cause of heel pain that persists despite usual treatments like physical therapy or steroid injections. This trial compares autologous bone marrow aspirate and platelet-rich fibrin injections to see their effects on pain and foot function, using ultrasound guidance to ensure accurate delivery. The study is randomized, double-blind, and focuses on both clinical outcomes and imaging changes in the plantar fascia. Participants receive a single ultrasound-guided injection of either bone marrow aspirate, taken from the back of the pelvic bone under local anesthesia, or platelet-rich fibrin prepared from their own blood. Both injections are performed after regional anesthesia of the tibial nerve and under sterile conditions. The trial includes two groups, each receiving one of these treatments on the plantar fascia of the affected foot. During the study, participants will be monitored for pain levels using the Visual Analog Scale and for any adverse events at multiple time points up to 24 months. Foot function is assessed with a special score at several visits, and ultrasound will measure plantar fascia thickness before treatment and one year later. The total follow-up allows researchers to evaluate both safety and effectiveness over time, contributing to understanding these regenerative therapies for heel pain.
CONDITIONS
Brief Title
Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Clinical diagnosis of chronic plantar fasciitis lasting more than 6 months confirmed by ultrasound
- Persistent heel pain not improved by conventional treatments like stretching, orthotics, physical therapy, or corticosteroid injections
- Baseline pain score of 4 or higher on the Visual Analog Scale
- Ability and willingness to follow study procedures and attend follow-up visits
- Signed informed consent
You will not qualify if you...
- Previous foot or ankle surgery on the affected limb
- Acute trauma, infection, or ulceration in the plantar fascia area
- Systemic inflammatory diseases such as rheumatoid arthritis, lupus, or psoriatic arthritis
- Metabolic or endocrine disorders that affect healing, including poorly controlled diabetes or thyroid disorders
- Current use of systemic corticosteroids, immunosuppressants, or anticoagulants
- Active cancer or blood disorders
- Pregnancy or breastfeeding
- Peripheral vascular disease or neuropathy in the lower limbs
- Contraindications to local anesthesia or blood draw procedures
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants receive a single ultrasound-guided injection of either autologous bone marrow aspirate or platelet-rich fibrin into the plantar fascia under regional anesthesia.
1 treatment visit (in-person)
Duration - 24 months
Participants are monitored for pain, function, and safety at multiple time points up to 24 months after the injection.
Visits at 30 minutes, 1, 6, 12, and 24 months post-procedure
Trial Site Locations
Total: 1 location
1
Federal University of São Paulo - Hospital São Paulo
São Paulo, Brazil, 04023-900
Actively Recruiting
Research Team
L
LUCAS FONSECA, MD
C
Carlos Franciozi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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