SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization

CrannMed45 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plantar Fascitis Heel Pain Musculoskeletal Diseases

Interventions

Arterial EmbolizationDEVICE

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 therapyDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Nano Medical Clinic

Tashkent, Uzbekistan, Uzbekistan

RECRUITING

Outcomes

Primary Outcomes

Primary Effectiveness Endpoint

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

Time frame: 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).

Time frame: 3 months

Central Contacts

Chief Operations Officer

CONTACT

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

Data from ClinicalTrials.gov

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