The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
5\*10/7 per ischemic limb
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China
Angiographic evaluation of angiogenesis at ischemic limb
Time frame: 6 months
Pain
Time frame: 3 months
Ankle-Brachial pressure index
Time frame: 3 months
Wound healing (wound size, wound stage)
Time frame: 3 months
Walking distance
Time frame: 3 months
Rate and extent of amputations
Time frame: 6 months
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