Using botulinum toxin injections to improve blood flow and heal severe leg ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of subcutaneous injections of botulinum toxin A on wound healing in patients suffering from lower extremity ischemia. It focuses on individuals with chronic ulcers caused by blocked blood vessels, particularly in elderly patients or those with diabetes. The methodology involves assessing the impact of botulinum toxin on blood flow and healing processes, leveraging its known effects on vasodilation and angiogenesis. Participants will be monitored for their response to the treatment over the course of the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
2. 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.)
3. Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
4. Those who have received botulinum toxin preparations within 3 months before screening
5. Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
6. 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
7. Those who are currently taking steroids or immunosuppressants that affect wounds, or those who have taken them within one month of screening
8. Those who have applied injection drugs or wound coverings that help improve wounds within 1 week of screening
9. 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).
10. Those who are allergic or sensitive to botulinum toxin
11. 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.
12. Those who are not suitable for this clinical trial under the judgment of other investigators

Where it's running

• Yongin Severance Hospital
  Yongin-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Hiisun J, Dr — Yonsei University College of Medicine, Yongin Severance
• Study coordinator: Hiisun J, Dr
• Email: hsjeongps@yuhs.ac
• Phone: 823151899730

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.