Actively Recruiting
SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
Led by CrannMed · Updated on 2025-11-21
45
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SakuraBead17 resorbable embolization microspheres compared with extracorporeal shockwave therapy (ESWT) for adults experiencing pain due to plantar fasciitis. This prospective, single-center, randomized, two-arm study aims to address pain caused by plantar fasciitis by comparing these two treatment methods. Approximately 45 patients will participate and be followed for six months to assess outcomes. Participants will be randomly assigned to one of two treatment groups. One group will receive arterial embolization, where resorbable microspheres are delivered through a microcatheter to temporarily block excessive blood flow in the targeted area, while preserving normal circulation. The other group will undergo ESWT, a non-invasive treatment using acoustic pulses to address the condition. Both treatments are delivered at the study center, and the safety and effectiveness will be compared over a 3-month period, with follow-ups extending to six months. Throughout the study, participants will undergo assessments to monitor safety and treatment effects, including measuring the primary effectiveness and safety endpoints at three months. Patients will receive clinical evaluations related to plantar fascia thickness and pain symptoms. The study includes thorough follow-up visits to track progress and adverse events. Participants' involvement will last at least six months, with ongoing monitoring to evaluate how each treatment affects their plantar fasciitis symptoms and overall foot health.
CONDITIONS
Brief Title
SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is able and willing to provide written informed consent
- Age 18 to 75 years (inclusive)
- Clinical diagnosis of plantar fasciitis with proximal plantar fascia thickness greater than 4mm and areas of hypoechogenicity
You will not qualify if you...
- Acute internal derangement of the foot including acute meniscal, ligament or bone injury
- Sensory or motor neuropathy of the feet
- Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis
- Prior surgical repair or plantar fascia rupture in the involved foot
- Local infection in either foot
- Contraindication to MRI
- Active pregnancy as demonstrated by urine or serum b2-hCG or lactating female
- Unable to provide informed consent or comply with the conditions of the study
- At the discretion of the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive either arterial embolization using resorbable microspheres or extracorporeal shockwave therapy to treat pain from plantar fasciitis.
1 treatment visit (in-person)
Duration - 6 months
Participants are monitored for safety and treatment effectiveness for pain secondary to plantar fasciitis.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Nano Medical Clinic
Tashkent, Uzbekistan, Uzbekistan, 100095
Actively Recruiting
Research Team
C
Chief Operations Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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