Clinical Research Directory

Inclusion Criteria: * Age above 18 years and under 95 years * History of diabetes mellitus with stable glycemic control (HbA1C\<10) * Clinical diagnosis of chronic limb-threatening ischemia * Stable Rutherford Classification 5 or 6 ischemic ulcer on foot * Subjects who are determined by an independent multidisciplinary team of surgical and endovascular experts to have no feasible conventional distal bypass surgical or endovascular therapy for limb salvage. * Subjects who are enrolled in an appropriate wound care network and have a sufficient support system to ensure compliance with medication regimens and follow-up study visits. * Subjects who are willing and able to provide informed consent Exclusion Criteria: * Frailty or severe comorbidities including significantly reduced cardiac, hepatic, renal and respiratory insufficiency making the subject not fit for surgery * Active malignancy or immunodeficiency disorder * Previous major amputation of the target limb or presence of a wound requiring a free flap * Life expectancy less than 12 months * Active infection at the time of the index procedure * Any significant concurrent medical, psychological, or social condition that, in the opinion of the investigator, may substantially interfere with the subject's optimal participation in the study. * Pregnancy at the time of enrolment * The subject participating in another investigational drug or device study that has not completed its primary endpoint or clinically interferes with the endpoints of this study. * The subject is unwilling or unable to comply with any protocol or follow-up requirements.