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

ConditionsChronic Ulcer of Lower ExtremityWoundBotulinum Toxins, Type ABlood Circulation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorYonsei University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Botulinum toxin A

    Drug

    subcutaneous injection of Botulinum toxin A

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Botulinum toxin AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

tcPO2 measurement

Time frame
Baseline/7days after IP/14days after IP

Secondary outcomes

1

Change in color-graded amount(using Thermal Imaging Camera) within Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)

color-graded amount(using Thermal Imaging Camera)

Time frame
Baseline/7days after IP/14days after IP
2

Changes in wound quality and area in photographs at 7 days and 14 days after IP compared to baseline(Pre-administration IP)

wound quality and area in photographs(Digital Camera)

Time frame
Baseline/7days after IP/14days after IP

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov
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