SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization

NCT07241884 | Recruiting

• 1 other identifier: CI580
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fascitis; Heel Pain; Musculoskeletal Diseases

Keywords

Fasciitis; Musculoskeletal disease; Foot disease; Heel Pain

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Compare the proportion of responders between the Investigational procedure and Control.

  3 Months

• Primary Safety Endpoint

  Freedom from device or procedure-related serious adverse events (SAE) following the index procedure (proportions will be compared between Investigational procedure and Control).

  3 months

Study Arms (2)

Arterial Embolisation

EXPERIMENTAL

Temporary embolization using resorbable microspheres

Device: Arterial Embolization

Shockwave

ACTIVE COMPARATOR

Extracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis.

Device: Extracorporeal shockwave therapy

Interventions

Arterial Embolization DEVICE

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.

Arterial Embolisation

Extracorporeal shockwave therapy DEVICE

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

Shockwave

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CrannMed: lead

Study Sites (1)

Nano Medical Clinic

Tashkent, Uzbekistan, 100095, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Fasciitis; Foot Diseases

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Chief Operations Officer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)