Phase 2 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older, of any gender
• People who have been diagnosed with critical limb ischemia (a serious condition where blood flow to the legs is severely reduced), with a severity rating of Rutherford score 4–6 (confirm with trial site)
• People who cannot have surgical or interventional treatment to restore blood flow, or whose previous such treatment did not work, or who do not wish to have such treatment — and who are currently being managed with antiplatelet and blood vessel-widening medications for at least 1 week before the study begins
• People whose leg artery scans (ultrasound or CT scan) show a serious blockage or narrowing in one or more of the major arteries in the leg or hip area
• People who have at least one of the following severe leg symptoms lasting 2 or more weeks: resting pain in the limb (with a pain score between 40mm and less than 100mm on a standard scale), OR a leg ulcer caused by poor blood flow (where the largest single ulcer is between 4cm² and 25cm² in size)
• People who are able and willing to use effective contraception from the time of signing consent until 3 months after the trial ends (applies to people who could become pregnant or whose partner could become pregnant)
• People who are willing to give informed consent, follow the trial procedures, and provide biological samples as required

Who may not be able to join:

• People with a known allergy to the study drug, its ingredients, or other human blood products
• People who have gangrene in a limb covering an area larger than 4cm²
• People who currently have, or have previously had, a cancer that has not been fully cured
• People who have liver or kidney failure (confirm with trial site)
• People who need regular dialysis (kidney filtering treatment)
• People who have had a stroke or brain bleed in the 3 months before signing consent
• People who have a mental illness, significant cognitive impairment, or epilepsy, or who are otherwise unable to make decisions for themselves
• People with high blood pressure that cannot be brought under control with standard treatment (specifically, a top reading of 160mmHg or more and/or a bottom reading of 100mmHg or more)
• People who have received certain blood products (including fresh plasma, cold precipitates, or products containing a specific component called TP03HN106) within 1 month before signing consent
• People who have taken part in another clinical drug or medical device trial within 1 month before signing consent
• People who have had surgery, or are planning surgery, within 1 month before or during the trial period
• People with heavy alcohol use (more than 21 standard drinks per week for men, or more than 14 per week for women), or people who use recreational drugs or are dependent on substances
• People who have had a miscarriage or termination of pregnancy within the 3 months before signing consent, as well as people who are currently pregnant or breastfeeding (including those who gave birth less than 6 months ago and are not using artificial feeding)
• People whose ability to follow the trial requirements is uncertain, or anyone the trial doctors consider unsuitable for other reasons

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