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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Arterial Embolization
DeviceResorbable 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.
Extracorporeal shockwave therapy
DeviceExtracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Arterial EmbolisationExperimental treatment 1 intervention
Group B: ShockwaveActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
Compare the proportion of responders between the Investigational procedure and Control.
Time frame
3 Months2
Primary Safety Endpoint
Freedom from device or procedure-related serious adverse events (SAE) following the index procedure (proportions will be compared between Investigational procedure and Control).
Time frame
3 months Source ClinicalTrials.gov