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Efficacy of combined treatment by autologous cell therapy and percutaneous transluminal angioplasty (PTA) versus the treatment by isolated PTA in diabetic patients with chronic limb-threatening ischemia
EU CTIS ID: 2024-512873-29-00
What this study is testing
The aim of the clinical trial is to compare the effect of the combination of cell therapy and PTA with the effect of PTA alone and to assess possible side effects and complications of both methods. Primary: rate of major amputation, wound healing, TcPO2.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA
- age 18-90 years
- diabetes mellitus type 1 or 2
- signed informed consent.
- 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.
You likely can't join if
- severe active deep infection of DFU
- breastfeeding women and women planning pregnancy at the time of the study
- deep vein thrombosis less than 6 months
- severe limb oedema that rule out intramuscular injection of cell suspension
- severe non-treated diabetic retinopathy requiring acutely a laser therapy
- severe haematological disease
See the full eligibility criteria
- 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
- presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA
- age 18-90 years
- diabetes mellitus type 1 or 2
- signed informed consent.
- 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.
- severe active deep infection of DFU
- breastfeeding women and women planning pregnancy at the time of the study
- deep vein thrombosis less than 6 months
- severe limb oedema that rule out intramuscular injection of cell suspension
- severe non-treated diabetic retinopathy requiring acutely a laser therapy
- severe haematological disease
- diagnosed neoplastic process of any organ less than 5 years
- expected life prognosis shorter than 6 months
- contracindication of general anestesia
- pregnant women – the test of pregnancy is the part of the examination before inclusion into the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.