RecruitingNot Applicable

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

Brazil72 participantsStarted 2025-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline (0), 30 minutes, 1, 6, 12, and 24 months

Trial details

NCT IDNCT07242729

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

Contact for this trial

LUCAS FONSECA, MD

+5511982148662 contato@drlucasfonseca.med.br

View on ClinicalTrials.gov More Plantar Fasciitis trials