Autologous bone marrow-derived mononuclear cells for Chronic limb-threatening ischemia | Diabetic foot ulcer

Inclusion criteria

• {"criterion_text":"- diabetic foot ulcers (DFU; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2C-3D, Wagner 2-4 or ischemic rest pain"}
• {"criterion_text":"- presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA"}
• {"criterion_text":"- age 18-90 years"}
• {"criterion_text":"- diabetes mellitus type 1 or 2"}
• {"criterion_text":"- signed informed consent."}
• {"criterion_text":"- females of childbearing potential must be willing for the duration of the study to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods."}

Exclusion criteria

• {"criterion_text":"- severe active deep infection of DFU"}
• {"criterion_text":"- breastfeeding women and women planning pregnancy at the time of the study"}
• {"criterion_text":"- deep vein thrombosis less than 6 months"}
• {"criterion_text":"- severe limb oedema that rule out intramuscular injection of cell suspension"}
• {"criterion_text":"- severe non-treated diabetic retinopathy requiring acutely a laser therapy"}
• {"criterion_text":"- severe haematological disease"}
• {"criterion_text":"- diagnosed neoplastic process of any organ less than 5 years"}
• {"criterion_text":"- expected life prognosis shorter than 6 months"}
• {"criterion_text":"- contracindication of general anestesia"}
• {"criterion_text":"- pregnant women – the test of pregnancy is the part of the examination before inclusion into the study"}

Primary endpoints

• {"endpoint_text":"- rate of major amputation, wound healing, TcPO2","definition_or_measurement_approach":"As stated in trial objectives: rate of major amputation, wound healing and TcPO2 (TcPO2 = transcutaneous oxygen tension). No further measurement details provided in the available data."}

Secondary endpoints

• {"endpoint_text":"- other ischemia parameteres – ABI, laser doppler flowmetry, magnetic resonance spectroscopy; optional: microbiopsy of the muscle of the foot","definition_or_measurement_approach":"As listed: assessment of ABI (ankle-brachial index), laser Doppler flowmetry, magnetic resonance spectroscopy; optional microbiopsy of foot muscle. No further measurement details provided."}
• {"endpoint_text":"- other clinical effect – pain","definition_or_measurement_approach":"Clinical assessment of pain; no specific pain scale or measurement method specified in available data."}
• {"endpoint_text":"- safety: adverse events – expected and unexpected","definition_or_measurement_approach":"Recording of adverse events (expected and unexpected). No further SAE/AE grading or definitions provided in available data."}
• {"endpoint_text":"- assessment of quality of life (standardized questionnaires)","definition_or_measurement_approach":"Quality of life assessed using standardized questionnaires (specific instruments not specified in provided data)."}

Czechia

Earliest CTIS Part Ii Submission Date

11-12-2024

Latest Decision Or Authorization Date

25-02-2025

Processing Time Days

76

Number Of Sites

1

Number Of Participants

110

Primary sponsor

Full Name

Institute For Clinical And Experimental Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia