SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arterial Embolization, Extracorporeal shockwave therapy.
- Who it may be relevant to
- Registry conditions: Plantar Fascitis, Heel Pain, Musculoskeletal Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uzbekistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- 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. - Device Extracorporeal shockwave therapy
Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.
Primary outcome measures
- Primary Effectiveness Endpoint [Time frame: 3 Months]
- Primary Safety Endpoint [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Uzbekistan · 1 center
- Nano Medical Clinic — Tashkent
Identifiers
NCT: NCT07241884 · CI580