Effect of TRI-001 in patients with chronic limb threatening ischemia

You may be able to join if

• Male or female adult patient, not older than 85 years of age, who have signed an informed consent form either directly or through a legally authorised representative.
• Objective evidence of CLTI due to PAD (Rutherford 5): a. Minor tissue loss, i.e., ischemic lesions must not have tendon or bone exposure (unless secondary to a minor amputation) b. Persistent, non-healing ischemic wound(s) which are: i. present during at least 2 weeks prior to screening, and ii. at least 1 wound with its surface area ≥3 cm2. iii. likely irreversible wounds (e.g., non healing for >52 weeks) may be excluded at the discretion of the Investigator. excluded at the discretion of the Investigator. c. The index leg is meeting haemodynamic and metabolic criteria assessed in two consecutive examinations performed at least one week apart prior to randomisation (see Section 8.1.8): i. Resting ankle systolic pressure (ASP) <60 millimetre of mercury (mm Hg) in either the dorsalis pedis or posterior tibial arteries; or ii. Resting toe systolic pressure (TSP) <40 mm Hg; or iii. Transcutaneous oxygen pressure (TcPO2) <30 mm Hg. d. Sufficient inflow of aorta, iliac, common femoral artery and profunda assessed by doppler ultrasonography at screening. Definition sufficient inflow is in accordance with the IWGFD PAD Guidelines (Fitridge 2023). e. The patient has no promising conventional approach or is ineligible for revascularisation (including medical, endovascular, or surgical), as confirmed by the iAC (see Section 4.2). The following no-option conditions are considered eligible: i. Type I: patients with no sufficient perfused pedal vessels or with desert foot anatomy ii. Type II: patients with potential pedal target vessel but without suitable autologous or allogenic conduit bypass and no option for endovascular revascularisation iii. Type IV: patients with excessive or prohibitive risk for the revascularisation due to: • comorbidities (e.g., hypertension, coronary artery disease, renal failure, and pulmonary dysfunction) • having undergone failed endovascular surgeries (minimally 2 attempts) or failed open surgeries (minimally 1 attempt). These patients are considered eligible if the iAC deems these patients unsuitable for revascularisation attempts.
• Patients with adequate organ function defined as following: a. Renal function: estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation (See Section 8.2.2) b. Hepatic function: i. Total bilirubin (TB) ≤1.5× upper limit of normal (ULN), and ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× ULN c. Bone marrow: i. Absolute neutrophil count ≥1.5× 109 cells/L ii. Haemoglobin ≥8.0 g/dL iii. Platelets ≥75× 109 cells/L
• Currently taking an anti platelet agent (e.g., clopidogrel, ticlopidine, and aspirin etc.) for 2 weeks or more prior to randomisation as part of their standard of care, unless contraindicated or anti-coagulated
• Patients of reproductive potential must agree to use an accepted and effective form of birth control methods during the study period. Contraceptive methods used by men or women should be consistent with Section 6.2.3 and local regulations.
• Willing and able to complete all study assessments, follow study instructions and attend all study visits as required, in the opinion of the Investigator