Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: 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.


Options:
A: 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
B: Inclusion Criteria:

* Patients 18 years of age or greater with atherosclerotic vascular disease that is viewed as not readily amenable to reconstructive surgery and Rutherford Category 4 ischemia (ischemic rest pain) and Rutherford Category 5 ischemia (ulceration or tissue necrosis) and by the judgment of their referring physician are not reasonable candidates for revascularization options of either percutaneous balloon angioplasty or a surgical revascularization.
* Objective evidence of severe peripheral arterial disease will include an ankle brachial index (ABI) of less than 0.5, or, in the case of patients who have vessels calcified and thereby "non-compressible" vessels metatarsal pulse volume recording (PVR) that is flat or barely pulsatile in the diseased limb on two consecutive examinations performed at least one week apart.
* Patients competent to give informed consent.
* No active malignant disease that could involve the bone marrow, or history of treatment of malignant disease that could have damaged the bone marrow.
* Before being accepted for the study the patient must be screened for human immunodeficiency virus, hepatitis B virus, hepatitis C virus, human transmissible spongiform encephalopathy, including Creutzfeldt-Jacob Disease, Treponema pallidum, and have a negative standard infectious disease panel including a CMV PCR test.
* Patients who are hemodynamically stable.

Exclusion Criteria:

* Patients with poorly controlled diabetes mellitus (HbA1C \> 8%)
* Patients with renal insufficiency (creatinine \> 2.5).
* Patients with evidence of infectious disease as determined by e. above or other medical findings.
* Pregnant women (women capable of childbearing must have a negative pregnancy test).
* Patients with cognitive impairments.
* Other comorbid disease that would be expected to result in less than one year life expectancy
* Past malignancy or history of chemotherapy or radiation affecting the bone marrow.
* History of inflammatory or progressively fibrotic conditions: .e.g., rheumatoid arthritis, systemic lupus erythematosis, vasculitic disorders, idiopathic pulmonary fibrosis, retroperitoneal fibrosis
* Infection as evidenced by WBC count of \>15,000 and/or temperature \>38 degrees C. Large area of cellulitis in the afflicted limb that in the opinion of the investigators would require the institution of antibiotics OR evidence of osteomyelitis corroborated by radiographic or scintigraphic examination
* Cardiovascular conditions:

  * Exercise limiting angina ( Canadian Cardiovascular Society Class 3 (Appendix 7);
  * Congestive heart failure (New York Heart Association class 3 (Appendix 5);
  * Unstable angina;
  * Acute ST elevation myocardial infarction (MI) within 1month;
  * Transient ischemic attack or stroke within 1 month;
  * Severe valvular disease
* Patients with any history of organ transplants;
C: Inclusion Criteria:

* Age \> 18
* Signature of informed consent
* Critical leg ischemia with ankle pressure \< 70 mmHg
* Ischemic ulcer or gangrene
* No possibility of surgical revascularization
* No possibility of angioplasty

Exclusion Criteria:

* Cancer
* Suspicion of a cancer on X-Ray, mammography or elevated PSA
* Age \< 18
* Life expectancy \< 6 months
* Active retinopathy
* Angioplasty or surgical revascularization within 3 months
* Stoke within 3 months
* HIV + or HCV/HBC+
D: Inclusion Criteria:

* Patients with unilateral critical chronic limb ischemia but not suitable candidates for non-surgical or surgical revascularization
* Before being included, the patient must be screened for human immunodeficiency virus, hepatitis B virus, hepatitis C virus, treponema pallidum

Exclusion Criteria:

* Buerger disease
* Ischemic ulcers with infectious symptoms
* Diabetes mellitus with HbA1c \> 7,5% or with proliferative retinopathy
* Past or current malignancy
* Contra-indication to general anaesthesia
* Chronic haemodialysis
* Prothrombin Time \< 60%,
* Recent onset (within 3 months) of myocardial infarction or brain infarction
* Coronary angioplasty within 1 year
* Atrial fibrillation, mechanical mitral prosthetic valve
* Unexplained hematological abnormality.
* Expected life span less than six months
* Patient not competent to give informed consent

Answer: A