RecruitingNot ApplicableNCT07241884

SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization

Sponsor

CrannMed

Enrollment

45 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Plantar Fascitis

Summary

This is a prospective, single center, double arm, randomized, unmasked, First in Human study that aims to evaluate the safety and effectiveness of SakuraBead™ resorbable embolization microspheres in adult patients suffering from pain secondary to plantar fasciitis.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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

Exclusion Criteria9

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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEArterial Embolization

Resorbable microspheres are delivered trans-arterially using a microcatheter or introducer sheath to the site of embolization where they will temporarily embolize the hypervascularity in the targeted region with preservation of normal arterial flow.

DEVICEExtracorporeal shockwave therapy

Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.