What is botulinum toxin A studying for chronic wounds caused by lower leg blood flow problems?

Botulinum toxin A is being studied to see if it can improve blood flow and help heal wounds caused by severe blood circulation issues in the lower legs. Researchers want to understand how this injection affects wound healing in patients whose blood vessels are narrowed or blocked. The study is led by Yonsei University to explore new treatment options for these chronic wounds.

Who may be eligible for this chronic ulcer clinical trial?

Adults aged 20 years or older with moderate to severe lower leg ischemia and wounds on their lower extremities may be eligible. Participants should not have had recent blood vessel procedures like angioplasty or botulinum toxin injections within 3 months. Both men and women can join, but pregnant or breastfeeding women are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic ulcer clinical trial?

Study-related care, including the botulinum toxin injection and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants can expect the study to cover treatments and assessments but should plan for travel costs independently.

Actively Recruiting

Phase 4

Age: 20Years +

All Genders

ID06878482

Study of Botulinum Toxin Injection to Improve Blood Flow and Heal Severe Lower Leg Wounds in Peripheral Artery Disease

Led by Yonsei University · Updated on 2025-03-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating how subcutaneous injections of botulinum toxin A affect healing of wounds caused by lower extremity ischemia, a condition where blood flow to the legs is reduced or blocked. This condition often affects elderly patients or those with diabetes, causing chronic wounds or ulcers due to narrowed or blocked blood vessels. The study focuses on patients with wounds on their feet where blood circulation relies mainly on collateral vessels.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 20 years or older
Diagnosed with moderate or severe lower extremity ischemia with a wound on the lower leg or foot
Unable to perform additional procedures like angioplasty based on vascular exams and CT angiography
Wound size between 1x1 cm and 3x3 cm
Able to follow the trial procedures and visit schedule
Provided written informed consent after understanding the study and restrictions

You will not qualify if you...

Diseases affecting neuromuscular function such as myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or motor neuropathy
Use of aminoglycoside antibiotics, muscle relaxants, or drugs inhibiting neuromuscular function within 4 weeks before screening
Use of aspirin, NSAIDs, or anticoagulants within 7 days before screening
Received botulinum toxin injections within 3 months before screening
One or more major lower leg blood vessels open on angiography or CT angiography
Blood flow preserved by balloon angioplasty despite blocked vessels
Current or recent use (within 1 month) of steroids or immunosuppressants affecting wounds
Applied injection drugs or wound coverings to improve wounds within 1 week before screening
Pregnant, lactating, planning pregnancy, or women of childbearing age not using contraception
Allergic or sensitive to botulinum toxin
Participation in another clinical trial within 30 days before screening or within the investigational product half-life
Judged unsuitable for the trial by investigators

Research Team

Hiisun J, Dr

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Study of Botulinum Toxin Injection to Improve Blood Flow and Heal Severe Lower Leg Wounds in Peripheral Artery Disease

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AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria