SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization (SURE-PF)

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Diseases; Plantar Fascitis; Heel Pain
• Intervention / Treatment: Device: Arterial Embolization; Device: Extracorporeal shockwave therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chief Operations Officer; Phone Number: +1 800 353 4246; Email: joan.mccabe@crannmed.com

Study Locations

• Uzbekistan
  • Uzbekistan
    • Tashkent, Uzbekistan, Uzbekistan, 100095
      • Recruiting
      • Nano Medical Clinic
      • Contact: Sherzod Iskhakov, MD; Phone Number: +998 90 943 4836; Email: siseptember8@gmail.com
      • Principal Investigator: Sherzod Iskhakov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arterial Embolisation; Temporary embolization using resorbable microspheres	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.
Active Comparator: Shockwave; Extracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis.	Device: Extracorporeal shockwave therapy; Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CrannMed

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Musculoskeletal disease; Fasciitis; Heel Pain; Foot disease
• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Musculoskeletal Diseases; Foot Diseases; Fasciitis; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: CI580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No