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Not yet recruitingPhase 2

Cell therapy plus artery widening for diabetic patients with severe leg circulation problems

Tests adding a person's own cells to angioplasty in diabetic chronic limb-threatening ischemia.

Key facts

Who runs it
Institute For Clinical And Experimental Medicine
Where
Czechia1 site in 1 countryChoose a country to see its sites
Registry title
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
Status
Not yet recruiting
Phase
Phase 2
People taking part
110 people, planned
Started
1 Jul 2025
Expected to end
30 Dec 2028
Type of study
Interventional
Record updated
25 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 or 2 diabetes who have poor blood flow that threatens a leg and a foot ulcer or rest pain. It compares cell therapy from the person's own cells plus balloon widening of the artery (PTA) with PTA alone.

Age
18-90 years
Sex
All sexes can join.
Disease stage
Chronic limb-threatening ischemia from proven artery blockage, with TcPO2 (skin oxygen level) under 40 mm Hg and a need for PTA. Also a diabetic foot ulcer below the ankle or a past minor amputation (TEXAS 2C-3D, Wagner 2-4), or ischemic pain at rest.
Biomarker or test result
TcPO2 under 40 mm Hg.

Main reasons for not taking part

  • Severe active deep infection of the foot ulcer
  • Pregnant or breastfeeding women, or women planning pregnancy
  • Deep vein clot in the last 6 months, or severe leg swelling
  • Cancer diagnosed in the last 5 years, or expected life under 6 months
  • Severe blood disease, severe untreated diabetic eye disease needing urgent laser, or unable to have general anaesthesia

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • severe non-treated diabetic retinopathy requiring acutely a laser therapy
  • severe active deep infection of DFU
  • deep vein thrombosis less than 6 months
  • severe haematological disease
  • breastfeeding women and women planning pregnancy at the time of the study
  • severe limb oedema that rule out intramuscular injection of cell suspension
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Cell therapy plus artery widening for diabetic patients with severe leg circulation problemsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
25 February 2025