Phase
Condition
Venous Leg Ulcers
Ulcers
Treatment
Botulinum toxin A
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 20 years old
Patients who have a lower extremity wound among those who have been diagnosed withmoderate or severe lower extremity ischemia
Patients who are unable to perform additional procedures (angioplasty, etc.) byperforming peripheral vascular examination and CT angiography
Wound size ≥ 1x1cm2 to ≤ 3x3cm2
Patients who can follow the clinical trial procedure well and abide by the visitschedule
Written informed consent to participate in the study after having fully understoodthe contents of the protocol and restrictions.
Exclusion
Exclusion Criteria:
Patients with diseases that can affect neuromuscular function, such as myastheniagravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motorneuropathy
Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, ordrugs that inhibit neuromuscular function (muscle relaxants, anticholinergics,benzodiazepines, benzamides, tetracyclines, Rinco Those who have taken mycinantibiotics, etc.)
Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
Those who have received botulinum toxin preparations within 3 months beforescreening
Angiography or CT angiography If one or more of the three major blood vessels in thelower extremity are open
Cases in which blood flow to the lower extremities can be preserved by performingballoon angioplasty even if all three major blood vessels in the lower extremity areblocked
Those who are currently taking steroids or immunosuppressants that affect wounds, orthose who have taken them within one month of screening
Those who have applied injection drugs or wound coverings that help improve woundswithin 1 week of screening
Women who are pregnant, lactating, planning to become pregnant during the clinicalperiod, or women of childbearing age who are not using available contraceptivemethods (women of childbearing age must be negative in the pregnancy test prior toinjection).
Those who are allergic or sensitive to botulinum toxin
Those who have participated in another clinical trial within 30 days beforescreening or those who have not passed the half-life of the investigational productof the clinical trial that they participated in, whichever is longer.
Those who are not suitable for this clinical trial under the judgment of otherinvestigators
Study Design
Study Description
Connect with a study center
Yongin Severance Hospital
Yongin-si, Gyeonggi-do 16995
Korea, Republic ofActive - Recruiting

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