Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease

Recruiting now · Phase 4

Conditions studied: Chronic Ulcer of Lower Extremity, Wound, Botulinum Toxins, Type A, Blood Circulation

In brief

The purpose of this study is to investigate the effect of subcutaneous injection of botulinum toxin A on wound healing caused by lower extremity ischemia.

Key facts

Study ID

NCT06878482

Run by

Yonsei University

People needed

15

Starts

2023-04-17

Expected to finish

2026-03-31

Last updated by the study team

2025-03-17

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 20 years old
• Patients who have a lower extremity wound among those who have been diagnosed with moderate or severe lower extremity ischemia
• Patients who are unable to perform additional procedures (angioplasty, etc.) by performing peripheral vascular examination and CT angiography
• Wound size ≥ 1x1cm2 to ≤ 3x3cm2
• Patients who can follow the clinical trial procedure well and abide by the visit schedule
• Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.

You may not qualify if…

• Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
• Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, Rinco Those who have taken mycin antibiotics, etc.)
• Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
• Those who have received botulinum toxin preparations within 3 months before screening
• Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
• Cases in which blood flow to the lower extremities can be preserved by performing balloon angioplasty even if all three major blood vessels in the lower extremity are blocked
• Those who are currently taking steroids or immunosuppressants that affect wounds, or those who have taken them within one month of screening
• Those who have applied injection drugs or wound coverings that help improve wounds within 1 week of screening
• Women who are pregnant, lactating, planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods (women of childbearing age must be negative in the pregnancy test prior to injection).
• Those who are allergic or sensitive to botulinum toxin
• Those who have participated in another clinical trial within 30 days before screening or those who have not passed the half-life of the investigational product of the clinical trial that they participated in, whichever is longer.
• Those who are not suitable for this clinical trial under the judgment of other investigators

Where it is running

• Yongin Severance Hospital — Yongin-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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