SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCrannMed
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 groupsSponsors and collaborators
Source ClinicalTrials.gov