Dissolvable SakuraBead embolization for plantar fascia pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center, randomized, unmasked, double-arm first-in-human trial compares SakuraBead™ resorbable embolization microspheres with extracorporeal shockwave therapy for treatment of pain from plantar fasciitis. About 45 adult patients will be randomized to one of the two treatments and followed for six months. Eligibility requires clinical plantar fasciitis with proximal plantar fascia thickness >4 mm and areas of hypoechogenicity on ultrasound. The study will capture safety outcomes and changes in heel pain over the follow-up period at Nano Medical Clinic in Tashkent, Uzbekistan.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is able and willing to provide written informed consent, and
2. Age 18 to 75 years (inclusive), and
3. Clinical diagnosis of PF with proximal plantar fascia thickness greater than 4mm and areas of hypoechogenicity.

Exclusion Criteria:

1. Acute internal derangement of the foot including acute meniscal, ligament or bone injury, or
2. Sensory or motor neuropathy of the feet, or
3. Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis, or
4. Prior surgical repair or plantar fascia rupture in the involved foot, or
5. Local infection in either foot, or
6. Contraindication to MRI, or
7. Active pregnancy as demonstrated by urine or serum β-hCG or lactating female
8. Unable to provide informed consent or comply with the conditions of the study, or
9. At the discretion of the Principal Investigator

Where it's running

• Nano Medical Clinic
  Tashkent, Uzbekistan, Uzbekistan Recruiting

Study contacts

• Study coordinator: Chief Operations Officer
• Email: joan.mccabe@crannmed.com
• Phone: +1 800 353 4246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.