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

CrannMed

Status: Enrolling

Conditions: Plantar Fascitis; Heel Pain; Musculoskeletal Diseases

Treatments: Device: Arterial Embolization; Device: Extracorporeal shockwave therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07241884

CI580

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Arterial Embolisation

Experimental group

Description:

Temporary embolization using resorbable microspheres

Treatment:

Device: Arterial Embolization

Shockwave

Active Comparator group

Description:

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

Treatment:

Device: Extracorporeal shockwave therapy