Plantar Fascitis, Heel Pain, Musculoskeletal Diseases
Conditions
Keywords
Fasciitis, Musculoskeletal disease, Foot disease, Heel Pain
Brief 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.
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.
Interventions
DEVICEArterial Embolization
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.
DEVICEExtracorporeal shockwave therapy
Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.
Sponsors
CrannMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is able and willing to provide written informed consent, and 2. Age 18 to 75 years (inclusive), and 3. Clinical diagnosis of PF with proximal plantar fascia thickness greater than 4mm and areas of hypoechogenicity.
Exclusion criteria
1. Acute internal derangement of the foot including acute meniscal, ligament or bone injury, or 2. Sensory or motor neuropathy of the feet, or 3. Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis, or 4. Prior surgical repair or plantar fascia rupture in the involved foot, or 5. Local infection in either foot, or 6. Contraindication to MRI, or 7. Active pregnancy as demonstrated by urine or serum β-hCG or lactating female 8. Unable to provide informed consent or comply with the conditions of the study, or 9. At the discretion of the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 3 Months | Compare the proportion of responders between the Investigational procedure and Control. |
| Primary Safety Endpoint | 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). |
Countries
Uzbekistan
Contacts
Primary ContactChief Operations Officer
Outcome results
None listed