RecruitingNot Applicable

SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization

Uzbekistan45 participantsStarted 2025-10-20

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Primary Effectiveness Endpoint

Timeframe: 3 Months

Primary Safety Endpoint

Timeframe: 3 months

Trial details

NCT IDNCT07241884

SponsorCrannMed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Chief Operations Officer

+1 800 353 4246 joan.mccabe@crannmed.com

View on ClinicalTrials.gov More Plantar Fascitis trials