Completed PHASE2/PHASE3 INTERVENTIONAL 4-arm NCT01818310

Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia (DIALEG)

Randomised Clinical Study of Safety and Efficacy of Autologous Bone Marrow Aspirate Concentrate (BMAC) for No-option_critical Limb Ischemia in Type-II Diabetes Mellitus Patients. (DIALEG)

Sponsor: Ministry of Health, Czech Republic

Conditions Critical Lower Limb Ischemia Type-2 Diabetes Mellitus

Interventions Group A: Intramuscular Group B: Intraarterial Group C: Intravenous Group D: Surgical endovascular treatment with maximum medicamentous treatment

Updated 9 times since 2017 Last updated: Sep 29, 2021 Started: Sep 30, 2012 Primary completion: Sep 30, 2018 Completion: Oct 31, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Critical Lower Limb Ischemia and Type-2 Diabetes Mellitus, this trial is completed. The trial is conducted by Ministry of Health, Czech Republic and has accumulated 9 data snapshots since 2012. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Oct 2021 — Jul 2024 [monthly]

Completed PHASE2_PHASE3

Status: Unknown Status → Completed
Jan 2021 — Oct 2021 [monthly]

Unknown Status PHASE2_PHASE3
Apr 2020 — Jan 2021 [monthly]

Unknown Status PHASE2_PHASE3

Status: Active Not Recruiting → Unknown Status

▶ Show 4 earlier versions

Jun 2018 — Apr 2020 [monthly]

Active Not Recruiting PHASE2_PHASE3
Apr 2018 — Jun 2018 [monthly]

Active Not Recruiting PHASE2_PHASE3
Mar 2017 — Apr 2018 [monthly]

Active Not Recruiting PHASE2_PHASE3

Status: Unknown Status → Active Not Recruiting · Phase: PHASE3 → PHASE2_PHASE3
Jan 2017 — Mar 2017 [monthly]

Unknown Status PHASE3

First recorded

Sep 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Ministry of Health, Czech Republic
Regional Council of the Moravian-Silesian region, KU MSK
University Hospital Ostrava

Data source: University Hospital Ostrava

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Ostrava, Czechia