Phase 4 Peripheral Arterial Disease Trial, Recruiting NCT06878482 Sponsor: Yonsei University Condition: Peripheral Arterial Disease
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Phase 4 Peripheral Arterial Disease Trial, Recruiting

NCT06878482
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 20 years or older
  • People who have been diagnosed with moderate or severe reduced blood flow in the lower legs and also have a wound on a lower limb
  • People whose doctors have determined, after vascular examination and CT imaging, that no further procedures (such as balloon angioplasty) are possible to improve blood flow
  • People whose wound measures at least 1×1 cm and no larger than 3×3 cm
  • People who are able to follow the trial schedule and attend all required visits
  • People who have read and fully understood the trial information and have given written agreement to participate

Who may not be able to join:

  • People with conditions that affect nerve or muscle function, such as myasthenia gravis, Eaton-Lambert syndrome, ALS (motor neurone disease), or motor neuropathy
  • People who have taken certain antibiotics (aminoglycosides, tetracyclines, lincomycin-type) or medications that affect muscle or nerve function (such as muscle relaxants, anticholinergics, benzodiazepines, or similar drugs) within 4 weeks before screening
  • People who have taken aspirin, anti-inflammatory pain medications (NSAIDs), or blood thinners within 7 days before screening
  • People who have received any botulinum toxin treatment within 3 months before screening
  • People where imaging shows that one or more of the three main blood vessels in the lower leg remains open (confirm with trial site)
  • People where doctors determine that balloon angioplasty could restore blood flow to the lower leg, even if all three main vessels are blocked
  • People currently taking, or who have taken within one month of screening, steroids or immune-suppressing medications that may affect wound healing
  • People who have used injectable medications or wound-covering products intended to help wound healing within 1 week before screening
  • People who are pregnant, breastfeeding, planning to become pregnant during the trial period, or women of childbearing age who are not using an available form of contraception
  • People with a known allergy or sensitivity to botulinum toxin
  • People who have participated in another clinical trial within 30 days before screening, or where the investigational product from a previous trial has not yet fully cleared the body — whichever period is longer
  • People whom the trial investigators determine are otherwise unsuitable for participation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

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

Phone: 823151899730

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
17 April 2023
Est. completion
31 March 2026

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

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)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov