NCT06878482 Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
| NCT ID | NCT06878482 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yonsei University |
| Condition | Chronic Ulcer of Lower Extremity |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 15 participants in total. It began in 2023-04-17 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Hiisun J, Dr
PRINCIPAL INVESTIGATOR
Yonsei University College of Medicine, Yongin Severance
Frequently Asked Questions
Who can join the NCT06878482 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Chronic Ulcer of Lower Extremity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06878482 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06878482 currently recruiting?
Yes, NCT06878482 is actively recruiting participants. Contact the research team at hsjeongps@yuhs.ac for enrollment information.
Where is the NCT06878482 trial being conducted?
This trial is being conducted at Yongin-si, South Korea.
Who is sponsoring the NCT06878482 clinical trial?
NCT06878482 is sponsored by Yonsei University. The principal investigator is Hiisun J, Dr at Yonsei University College of Medicine, Yongin Severance. The trial plans to enroll 15 participants.