Randomised clinical study of critical limb ischemia patients with foot ulcer and type II diabetes mellitus that will be treated with autologous bone marrow stemm cells derrived from iliac crest bone marrow aspirate and separated with SmartPReP2 separator with either intramuscular or intravenous aplication with monitoring major limb amputation prevention, metabolic and imunological parameters.

Randomised clinical study of autologous bone marrow aspirate concentrate (BMAC) activity fo No_option_critical limb ischemia in Type-II diabetes mellitus (DILAEG) - DIALEG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001825-28-CZ

Enrollment

Registered

2012-08-20

Start date

2012-08-20

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No-option critical limb ischemia patients with T2DM and foot ulcers

Interventions

Trade Name: Autologous bone marrow stem cells aspirate concentrate (BMAC) Product Name: Autologous bone marrow aspirate concentrate (BMAC) Product Code: BMAC Pharmaceutical Form: Concentrate for solut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: 2years follow-up	—

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026