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

March 11, 2025 updated by: Hii Sun Jeong, Yonsei University

Effect of Increasing Blood Flow by Botulinum Toxin Local Injection for Severe Peripheral Artery Occlusive Disease: Preliminary Report

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tissues below the calf are governed by blood flow from the anterior tibial artery, peroneal artery, and posterior tibial artery. When an ulcer occurs due to acute lower extremity ischemia, one of the three blood vessels is blocked by a blood clot, or when the blood vessel is narrowed due to perivascular inflammation, such as Buerger's disease, it occurs in a subacute or chronic form. In particular, in the case of elderly patients with ulcers or diabetic feet due to lower extremity ischemia, the symptoms are often worsened by chronic narrowing of blood vessels due to arteriosclerosis or blockage by blood clots. To treat this, prostaglandin or antithrombotic drugs are taken, and blood flow is resumed through stent surgery, but in the lower extremities, the recurrence rate is relatively high because the blood vessels are smaller than the iliac artery, femoral artery, and popliteal artery.

Botulinum toxin is known to have a positive effect on wound healing and blood flow improvement. Botulinum toxin has been published several times in papers showing its spasmolytic effect by participating in the radiographic hip osteoarthritis Ras homolog A (RhoA)/Rock-assisted protein kinase (ROCK) pathway. In addition, botulinum toxin has a vasodilating effect related to the calcitonin gene-related peptide (CGRP) pathway, and is involved in increasing vascular endothelial growth factor (VEGF) from NO-mediated angiogenesis, inhibiting vasoconstriction, increasing blood flow rate, and promoting angiogenesis.

In this study, in patients with chronic wounds on the feet, whose lower extremity blood vessels circulate mainly through collateral circulation, subcutaneous injection of Botulinum toxin in and around the wound improves blood flow around the wound and confirms the degree of wound healing.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital
        • Contact:
          • Hiisun Jeong, doctor
        • Principal Investigator:
          • Hiisun Jeong, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin A
Single group(Botulinum toxin A) Open label
Drug: Botulinum toxin A
subcutaneous injection of Botulinum toxin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline/7days after IP/14days after IP
tcPO2 measurement
Baseline/7days after IP/14days after IP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline/7days after IP/14days after IP
color-graded amount(using Thermal Imaging Camera)
Baseline/7days after IP/14days after IP
Changes in wound quality and area in photographs at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
Time Frame: Baseline/7days after IP/14days after IP
wound quality and area in photographs(Digital Camera)
Baseline/7days after IP/14days after IP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hiisun J, Dr, Yonsei University College of Medicine, Yongin Severance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2023-0006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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