Diabetic foot ulcer. Diabetes mellitus
Conditions
Interventions
Intervention 1: Peripheral blood derived mononuclear cells injection (intra muscular in 60 sites in 3x3 cm distance, 1-1.5cm deep) in intervention group. Intervention 2: Standard therapy (wound debarm
Treatment - Other
Peripheral blood derived mononuclear cells injection (intra muscular in 60 sites in 3x3 cm distance, 1-1.5cm deep) in intervention group
Standard therapy (wound debarment and antibiotic therapy ) in both groups
Granulocyte Colony Stimulating Factor (GCSF) injection in both groups
Sponsors
EMRC
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Subjects with unilateral or bilateral diabetic critical limb ischemia; age 18-75, size of ulcer<10, Cr<2.5; Lower extremity ulcers of grade =2 Wagner’s classification; After failed surgical or Radiological interventional option for re-vascularization as confirmed by A vascular surgeon. Exclusion criteria: Recent occurrence (within 3 months) of myocardial infarction or brain infarction; Existing vital organ dysfunction, including heart , lung or kidneys (creatinine=2.5); Coagulation disorders; Pregnant women ( women capable of childbearing must have a negative pregnancy test; Any past or present malignancy; Treatment with immunosuppressive therapy.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing. Timepoint: 2-4 weeks. Method of measurement: Healing value. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of blood circulation. Timepoint: 3 months. Method of measurement: Improvement of ankle-brachial index (ABI) & Doupler Sonography criterias. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammadzadeh
Tehran university of Medical sciences
Outcome results
None listed