Plantar FasciitisfasciitisNCT07242729
Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis
A study testing Bone Marrow Aspirate Injection and Platelet-Rich Fibrin Injection in people with Plantar Fasciitis, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Bone Marrow Aspirate Injection and Platelet-Rich Fibrin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2025to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnancy or breastfeeding.
- Peripheral vascular disease or neuropathy affecting the lower limbs.
- Contraindications to local anesthesia or venipuncture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Franciozi, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Federal University of São Paulo - Hospital São Paulo
São Paulo, 04023-900
Lucas Fonseca, MD, +55 11 98214-8662, contato@drlucasfonseca.med.br
Lucas Fonseca, MD
About this study
Official title: Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical 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.
Read the 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
- Being tested
- Bone Marrow Aspirate Injection, Platelet-Rich Fibrin Injection
- Keywords
- Plantar Fasciitis; Bone Marrow Aspirate; Platelet-Rich Fibrin; Ultrasound-Guided Injection; Regenerative Medicine
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate InjectionBiological
Also called BMA
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 InjectionBiological
Also called PRF
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Platelet-Rich Fibrin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (0), 30 minutes, 1, 6, 12, and 24 months
Secondary outcomes (2)
Change in Modified AOFAS Score
Improvement in the American Orthopaedic Foot and Ankle Society (AOFAS) score compared to baseline, reflecting pain and function.
Measured: baseline, 1, 6, 12, 24 months
Change in Plantar Fascia Thickness by Ultrasound
Variation in plantar fascia thickness (in millimeters) evaluated by ultrasound before the procedure and at 12 months.
Measured: Pre-procedure (baseline) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo de Almeida Mastrorosa, Federal University of São Paulo
- Investigators
- Lucas Fonseca, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242729
- Sponsor's protocol ID
- CAAE 90411925.0.0000.5505
- Acronym
- fasciitis
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that support the findings of this study will be made available upon reasonable request after publication of the main results. Data will be shared with qualified researchers for academic purposes only, upon approval by the principal investigator and the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07242729
- Acronym / sponsor ID
- fasciitis / CAAE 90411925.0.0000.5505
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fasciitis; Bone Marrow Aspirate; Platelet-Rich Fibrin; Ultrasound-Guided Injection; Regenerative Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Aspirate (BMA) Group | Experimental | Biological: Bone Marrow Aspirate InjectionParticipants 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. |
| Platelet-Rich Fibrin (PRF) Group | Experimental | Biological: Platelet-Rich Fibrin InjectionParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspirate InjectionAlso: BMAUltrasound-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. | Biological | Bone Marrow Aspirate (BMA) Group |
| Platelet-Rich Fibrin InjectionAlso: PRFUltrasound-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. | Biological | Platelet-Rich Fibrin (PRF) Group |
Primary outcome
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.
2 secondary outcomes
Change in Modified AOFAS Score
Time frame: baseline, 1, 6, 12, 24 months
Change in Plantar Fascia Thickness by Ultrasound
Time frame: Pre-procedure (baseline) and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that support the findings of this study will be made available upon reasonable request after publication of the main results. Data will be shared with qualified researchers for academic purposes only, upon approval by the principal investigator and the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Franciozi, PhD contact
Lucas Fonseca principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspirate Injection and Platelet-Rich Fibrin Injection in people with Plantar Fasciitis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LUCAS FONSECA, MD (+5511982148662, contato@drlucasfonseca.med.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (VAS) and occurrence of adverse events (time frame: baseline (0), 30 minutes, 1, 6, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.