An interventional study of Arterial Embolization and Extracorporeal shockwave therapy in Plantar Fascitis, Heel Pain and Musculoskeletal Diseases, sponsored by CrannMed. Recruiting at 1 site in Uzbekistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by CrannMed · Not applicable, Interventional, and Treatment
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.
To compare safety and efficacy of SakuraBead with shockwave therapy for the treatment of pain secondary to plantar fasciitis. Treatment will be performed on a total of approximately 45 patients who will be followed up for a period of 6 months.
16 studies on the registry are indexed under Fasciitis; 3 are open to participants now.
Browse Fasciitis studies →CrannMed is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Fasciitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Musculoskeletal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Temporary embolization using resorbable microspheres
Device: Arterial Embolization
Extracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis.
Device: Extracorporeal shockwave therapy
Resorbable 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 (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.
Primary Effectiveness Endpoint
Compare the proportion of responders between the Investigational procedure and Control.
Time frame: 3 Months
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2026, 8 months after the start.
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