Dissolvable SakuraBead embolization for plantar fascia pain
SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
This trial will try dissolvable SakuraBead embolization in adults with plantar fasciitis to see if it reduces heel pain better than shockwave therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | CrannMed Industry-sponsored |
| Locations | 1 site (Tashkent, Uzbekistan) |
| Trial ID | NCT07241884 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center, randomized, unmasked, double-arm first-in-human trial compares SakuraBead™ resorbable embolization microspheres with extracorporeal shockwave therapy for treatment of pain from plantar fasciitis. About 45 adult patients will be randomized to one of the two treatments and followed for six months. Eligibility requires clinical plantar fasciitis with proximal plantar fascia thickness >4 mm and areas of hypoechogenicity on ultrasound. The study will capture safety outcomes and changes in heel pain over the follow-up period at Nano Medical Clinic in Tashkent, Uzbekistan.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with symptomatic plantar fasciitis, ultrasound-confirmed proximal plantar fascia thickness >4 mm with hypoechogenicity, able to provide informed consent and attend follow-up visits.
Not a fit: Patients with heel pain from stress fractures, nerve entrapment, inflammatory conditions, prior plantar fascia surgery or rupture, local foot infection, sensory/motor neuropathy, pregnancy or MRI contraindications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive, absorbable embolic option that reduces heel pain and may avoid or delay surgery.
How similar studies have performed: This is a first-in-human use of SakuraBead for plantar fascia embolization; arterial embolization approaches for related musculoskeletal pain have shown preliminary positive but limited evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tashkent, Uzbekistan
- Nano Medical Clinic — Tashkent, Uzbekistan, Uzbekistan (Recruiting)
Study contacts
- Study coordinator: Chief Operations Officer
- Email: joan.mccabe@crannmed.com
- Phone: +1 800 353 4246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.