Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Arterial Embolization
  • Extracorporeal shockwave therapy

Treatment groups

45 Participants
are divided into 2 treatment groups

Locations

1
Nano Medical Clinic100095, TashkentUzbekistan, Uzbekistan

Sponsors and collaborators

CrannMed

Lead sponsor

Source ClinicalTrials.gov