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Critical Lower Limb IschemiaPhase 2/3DIALEGNCT01818310

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

A Phase 2/3 study testing Group A: Intramuscular, Group B: Intraarterial and Group C: Intravenous in people with Critical Lower Limb Ischemia and Type-2 Diabetes Mellitus, run by University Hospital Ostrava at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Group A: Intramuscular, Group B: Intraarterial and Group C: Intravenous
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCzechia
Study dates
Sep 2012to Oct 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • type 2 diabetes mellitus
  • diagnosis of critical limb ischemia
  • non-healing defect on the study limb
  • ABI value < 50 mmHg or ABI< 0.4
  • TBI value < 40 mmHg or TBI < 0.4
  • TcPO2 < 20 mmHg in supine position
Show all 9Show fewer
  • no other suitable surgical or re-vascularization procedure
  • age > 18 years
  • signed Informed Consent

Who cannot join

  • non-signing of the Informed Consent
  • anticipated life expectancy < 6 months
  • history of bone-marrow disease
  • renal failure or dialysis dependency
  • known malignant disease
  • health risks excluding the possibility of general anaesthesia or sedation
Show all 11Show fewer
  • life-threatening ischaemic heart disease
  • vast necrosis of the index limb
  • active infectious disease, or ATB treatment
  • treatment with immunosupressives
  • pregnancy, breastfeeding

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • University Hospital Ostrava

    Ostrava, 708 52

Other trials in Czechia

About this study

Official title: 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)

The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.

Read the detailed description

Secondary hypothesis assumes, that the intravenous application of BMAC in patients with T2DM older than 30 years of age, with a dose of insulin exceeding 0.7 U/kg/day or 50U/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glycHBA1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of BMAC.

Being tested
Group A: Intramuscular, Group B: Intraarterial, Group C: Intravenous, Group D: Surgical endovascular treatment with maximum medicamentous treatment
Keywords
ischemia, diabetes mellitus, bone marrow aspirate concentrate (BMAC)
Medical subject headings
Ischemia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A: IntramuscularBiological

    Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml.

    The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes.

  • Group B: IntraarterialBiological

    Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.

  • Group C: IntravenousBiological

    Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.

  • Group D: Surgical endovascular treatment with maximum medicamentous treatmentProcedure or surgery

    Group D: Control Group Control Group - no experimental intervention, standard endovascular treatment or bypass surgery or maximum medicamentous treatment

Study groups in NCT01818310
Study groupRoleWhat they receive
Group A: IntramuscularExperimentalIntramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml. The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes.
Receives: Biological: Group A: Intramuscular
Group B: IntraarterialExperimentalIntraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.
Receives: Biological: Group B: Intraarterial
Group C: IntravenousExperimentalGroup C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.
Receives: Biological: Group C: Intravenous
Group D: Control-standard treatmentOtherGroup D: Control Group Study subjects in Group D will receive a standard treatment for NO-option CLI.
Receives: Procedure: Group D: Surgical endovascular treatment with maximum medicamentous treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amputation-free survival

    The data for Primary outcome will be collected throughout the first 18 months of the study. The assessed parameters will include amputation-free survival in order to verify the safety and efficacy of the treatment.

    Measured: 18 months

Secondary outcomes (4)

  1. Tissue perfusion parameters

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Increase of the monitored parameters of the tissue perfusion measured with LDP-Periflux 5000 (Perimed), i.e. increase of the ABI - ankle-brachial index, TP - toe pressure, TBI- Toe Brachial index and TcpO2- transcutaneous oxygen pressure.
    • Decrease of the SPP perfusion parameter - skin perfusion pressure reflecting an inflammatory activity of the affected limb.

    Measured: 4 years

  2. Clinical outcome classification

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Improvement of the Rutherford scale of CLI

    Measured: 4 years

  3. Functional angiogenesis imaging outcome

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Increase of the number and quality of newly created vessels measured according to digital subtraction angiography (DSA) or MR-angiography (in allergic patients)

    Measured: 4 years

  4. Quality of life outcome

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Measurable decrease of pain measured on the scale and QOL questionnaire (RAND-36).
    • Healing of the defect or gangrene (size and state of the wound)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2018
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01818310
Sponsor's protocol ID
2012-T2DM-CLI
Other IDs
2012-001825-28
Acronym
DIALEG
Status last verified
Sep 2021
First submitted
27 Sep 2012
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Dormandy J, Heeck L, Vig S. The natural history of claudication: risk to life and limb. Semin Vasc Surg. 1999 Jun;12(2):123-37.

    PubMed 10777239

  • Clair DG, Dayal R, Faries PL, Bernheim J, Nowygrod R, Lantis JC 2nd, Beavers FP, Kent KC. Tibial angioplasty as an alternative strategy in patients with limb-threatening ischemia. Ann Vasc Surg. 2005 Jan;19(1):63-8. doi: 10.1007/s10016-004-0136-0.

    PubMed 15714369

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Group A: Intramuscular, Group B: Intraarterial and Group C: Intravenous in people with Critical Lower Limb Ischemia and Type-2 Diabetes Mellitus, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amputation-free survival (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01818310, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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