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NCT Number: NCT07241884

SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization

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.

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Key information

Conditions

Plantar Fascitis Fasciitis Foot Diseases Heel Pain Musculoskeletal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nano Medical Clinic

Tashkent, Uzbekistan, 100095

Location status: Recruiting

Location contact

Sherzod Iskhakov, MD

CONTACT

[email protected]

+998 90 943 4836

Sherzod Iskhakov, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • At the discretion of the Principal Investigator

Treatment and study plan

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.

Extracorporeal shockwave therapy

Device

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

Primary outcomes

  1. Primary Effectiveness Endpoint

    Time frame: 3 Months

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

  2. Primary Safety Endpoint

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Operations Officer

CONTACT

[email protected]

+1 800 353 4246

Sponsors and collaborators

Lead sponsor

CrannMed

Industry

Registry information

Acronym: SURE-PF

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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