Plantar FascitisSURE-PFNCT07241884
SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
A study testing Arterial Embolization and Extracorporeal shockwave therapy in people with Plantar Fascitis and Heel Pain, run by CrannMed at 1 site in Uzbekistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fascitis, Heel Pain, Musculoskeletal Diseases
- What is being tested?
- Arterial Embolization and Extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUzbekistan
- Study dates
- 20 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Local infection in either foot, or
- Contraindication to MRI, or
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- Active pregnancy as demonstrated by urine or serum β-hCG or lactating female
- Unable to provide informed consent or comply with the conditions of the study, or
- At the discretion of the Principal Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uzbekistan1 site, 1 recruiting
- Recruiting
Nano Medical Clinic
Tashkent, Uzbekistan, 100095
Sherzod Iskhakov, MD, +998 90 943 4836, siseptember8@gmail.com
Sherzod Iskhakov, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Plantar Fascitis, Heel Pain, Musculoskeletal Diseases
- Being tested
- Arterial Embolization, Extracorporeal shockwave therapy
- Keywords
- Fasciitis, Musculoskeletal disease, Foot disease, Heel Pain
- Medical subject headings
- Musculoskeletal Diseases, Fasciitis, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial EmbolizationDevice
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 therapyDevice
Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.
| Study group | Role | What they receive |
|---|---|---|
| Arterial Embolisation | Experimental | Temporary embolization using resorbable microspheres Receives: Device: Arterial Embolization |
| Shockwave | Active comparator | Extracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis. Receives: Device: Extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Compare the proportion of responders between the Investigational procedure and Control.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start20 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CrannMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241884
- Sponsor's protocol ID
- CI580
- Acronym
- SURE-PF
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
- ClinicalTrials.gov ID
- NCT07241884
- Acronym / sponsor ID
- SURE-PF / CI580
- Conditions
- Plantar Fascitis, Heel Pain, Musculoskeletal Diseases
- Keywords
- Fasciitis, Musculoskeletal disease, Foot disease, Heel Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- CrannMedIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arterial Embolisation | Experimental | Device: Arterial EmbolizationTemporary embolization using resorbable microspheres |
| Shockwave | Active comparator | Device: Extracorporeal shockwave therapyExtracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
- Local infection in either foot, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial EmbolizationResorbable 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. | Device | Arterial Embolisation |
| Extracorporeal shockwave therapyExtracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis. | Device | Shockwave |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 3 Months
Compare the proportion of responders between the Investigational procedure and Control.
Primary Safety Endpoint
Time frame: 3 months
Freedom from device or procedure-related serious adverse events (SAE) following the index procedure (proportions will be compared between Investigational procedure and Control).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Embolization and Extracorporeal shockwave therapy in people with Plantar Fascitis and Heel Pain, run by CrannMed at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Operations Officer (+1 800 353 4246, joan.mccabe@crannmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.