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NCT Number: NCT01065337

Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent [BOLD]). Patients also underwent imaging with angiographic methods.

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Key information

Conditions

Diabetic Foot Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Disease Attributes Endocrine System Diseases Foot Ulcer Ischemia Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herz- und Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, 32545, Germany

About this study

Diabetic foot (DF) is a concomitant illness of diabetes mellitus. Diabetes is one of the main causes of non-traumatic amputation worldwide due to severe peripheral arterial occlusive disease with chronic critical limb ischemia being the most abundant problem. Ulceration occurs as failure of oxygenation, nutrient supply and progressive occlusion of larger blood vessels often exacerbates pre-existing microvascular abnormalities.

Purified bone marrow mononuclear cells or expanded bone marrow cells enriched in Cluster of Differentiation 90+ (CD90+) mesenchymal stem cells (named tissue repair cells, [TRCs]) are used in the treatment of diabetic ulcers in comparison to bone marrow derived stem cells to induce revascularization of the affected limb and to enhance local perfusion. Cells are administered intramuscular or intraarterial. A control group of patients treated according national guidelines without stem cells serves as comparator.

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent [BOLD]). Patients also underwent imaging with angiographic methods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus Type 1 or 2
  • Peripheral occlusive arterial disease stage III or IV (Fontaine) with chronical ischemia, chronic foot ulcer, degree of severity <5 (Wagner), older than 6 weeks, without acute wound infection
  • Ulcer size 1 - 30cm2, in case of osteomyelitis only one bone should be affected no trend towards healing in the ulcer after one week of standard treatment
  • Angiopathic or angioneuropathic diabetic foot syndrome with no possible option of operative or interventional revascularisation
  • Age 18 - 80 years
  • Declaration of patient consent

Treatment and study plan

tissue repair cells (TRC)

Biological

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells

bone marrow stem cells (BMC)

Biological

bone marrow stem cells

Primary outcomes

  1. The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred

    Time frame: 12 months

Secondary outcomes

  1. Rate major amputations Rate of patients with complete ulcer healing Rate of treatment related complications Improvement of ankle brachial index (ABI) Improvement of transcutaneous oxygen partial pressure (TcPO2) Improvement of local perfusion

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 9, 2010
Registry last updated
May 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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