Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease (NCT06878482) | Clinical Trial Compass
RecruitingPhase 4
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
South Korea15 participantsStarted 2023-04-17
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
✕. 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
What they're measuring
1
Change in tcPO2(mmHg) measurement within the edge of 1cm Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
Timeframe: Baseline/7days after IP/14days after IP
✕. 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