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

NCT06878482 | Recruiting Phase 4 DMC

• 1 other identifier: 9-2023-0006
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ulcer of Lower Extremity; Wound; Botulinum Toxins, Type A; Blood Circulation

Keywords

Botulinum Toxins, Type A; Wound; Chronic Ulcer of Lower Extremity; Blood Circulation

Outcome Measures

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

  Baseline/7days after IP/14days after IP

Secondary Outcomes (2)

• 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)

  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)

  Baseline/7days after IP/14days after IP

Study Arms (1)

Botulinum toxin A

EXPERIMENTAL

Single group(Botulinum toxin A) Open label

Drug: Botulinum toxin A

Interventions

Botulinum toxin A DRUG

subcutaneous injection of Botulinum toxin A

Botulinum toxin A

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.

You may not qualify if:

• 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
• 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 the pregnancy test prior to injection).
• 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 is longer.
• Those who are not suitable for this clinical trial under the judgment of other investigators

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 16995, South Korea

RECRUITING

Related Publications (1)

• Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.

  PMID: 27997734 RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hiisun J, Dr

  Yonsei University College of Medicine, Yongin Severance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiisun J, Dr

CONTACT

823151899730; hsjeongps@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: March 17, 2025
• Study Start: April 17, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

KR (1)