NCT07241884

SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: CrannMed · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To compare safety and efficacy of SakuraBead with shockwave therapy for the treatment of pain secondary to plantar fasciitis. Treatment will be performed on a total of approximately 45 patients who will be followed up for a period of 6 months.

Conditions

• Plantar Fascitis
• Heel Pain
• Musculoskeletal Diseases

Interventions

Type	Name	Description
DEVICE	Arterial 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.
DEVICE	Extracorporeal shockwave therapy	Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-06-01
• Completion: 2027-03-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Uzbekistan