Augmenting ischemia-induced vasculo- and angiogenesis after endovascular reperfusion with host-extracted, percutaneously introduced, leucocyte- and platelet-rich fibrin in patients with critical limb ischemia

Phase 1

Recruiting

Conditions: critical limb ischemia

Registration Number: 2024-518657-42-00

Lead Sponsor: Medical University Of Warsaw

Brief Summary: The primary objective of the study is to assess the safety of using L-PRF in the treatment of critical limb ischemia

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

To finalize ICF for participation in the study and post-operative rehabilitation.

Symptomatic occlusive atherosclerosis of the lower limb arteries at stages 4 and 5 of the Rutherford scale (critical limb ischemia) confirmed clinically and hemodynamically.

Patients aged 18 years and older, under 90 years old.

Patients without absolute contraindications for undergoing revascularization procedures.

Expected average survival time: more than 3 years (patients will be eligible for the study if their expected perioperative mortality is <5% and the probability of predicted 2-year survival is >50%—such patients will be classified as having medium or high surgical risk).

Exclusion Criteria

To not accept the ICF to participate in the clinical study.

Inability to qualify the patient as a tissue donor due to history or diagnostic test results aimed at detecting contraindications for being a tissue or cell donor, including the presence of biological pathogens as defined by the Act on the Procurement, Storage, and Transplantation of Cells, Tissues, and Organs (Journal of Laws 2005 No. 169 item 1411) and included in the donor qualification form for the Tissue and Cell Bank (Attachment BT01).

Projected life time shorter than 3 years.

Active cancer (5-year washout period after treatment completion).

Other comorbidities that shorten the expected survival time to <3 years.

Neurological or psychiatric conditions that, in the investigator's opinion, would prevent adequate cooperation.

Abnormal hematological and biochemical parameters: Hemoglobin: <9.5 g/dl, Platelet count: <50,000/mm³, Bilirubin level: 3 times above the permissible upper limit of normal, AST: 3 times above the permissible upper limit of normal, ALT: 3 times above the permissible upper limit of normal, GFR: below 30 ml/min/1.73 m² (renal failure).

Absolute contraindications for the use of contrast agents (iodine-based, gadolinium-based, or 18FDG (18F-fluorodeoxyglucose)).

Participation in any other clinical trial or therapeutic experiment (washout period of no less than 120 days)

Women: pregnancy or positive pregnancy test at the time of inclusion in the study, and non-use of contraception (mechanical or hormonal), or declaration of non-use of contraception (mechanical or hormonal, except in cases of physical sterilization) during the study for premenopausal women. Women in the lactation period.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.		Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.		Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.

Trial Locations

Locations (1): Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
🇵🇱
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
🇵🇱Warsaw, Poland
Rafał Maciąg
Site contact
48602767223
rafal.maciag1@wum.edu.pl