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New treatment option for Chronic Ulcer of Lower Extremity
Official title Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
ClinicalTrials.gov ID: NCT06878482
What this study is testing
What is Botulinum toxin A?
Botulinum toxin A is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic ulcer of lower extremity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join 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
You likely can't join if
- Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis...
- Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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...
- Those who are not suitable for this clinical trial under the judgment of other investigators
The study team makes the final eligibility decision.
Where it's taking place
- Yongin-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yongin-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.