Diabetic Foot Clinical Trial
Official title:
A Randomized, Controlled, Parallel Design, Safety and Efficacy Study of Granulocyte Colony Stimulating Factor Mobilized Autologous Peripheral Blood Mononuclear Cell Therapy in Subjects With Diabetic Limb Ischemia.
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment 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.
One devastating complication of diabetes is peripheral arterial disease (PAD) including
critical limb ischemia (CLI), which may result in limb loss. Epidemiological evidence
confirms an association between diabetes and increased prevalence of peripheral arterial
disease (PAD). The prevalence of peripheral vascular disease among the Indian diabetic
population is 13%.
This therapy provides a targeted approach i.e. by improving blood perfusion in the ischemic
area of the lower limb by inducing neovascularization, which would be further evaluated by
measuring the change in transcutaneous partial pressure of oxygen (TCpO2), NMR angiography
of local vessels, ulcer healing, pain relief, limb salvage, ABI index etc.
The specific design of the trial enables us to differentially study the effect of stem cell
on diabetic foot CLI as compared to G-CSF (granulocyte colony stimulating factor) in (one
control group) and standard therapy (in another control group), this study would also
evaluate the effect of stem cell dose.
Extracting stem cells from this method is far more easy to perform as compared to extracting
from bone marrow and is less painful for the patient as well.
The yield of mononuclear stem cell from peripheral blood is much higher as compared to bone
marrow and role of CD34+ cells in limb ischemia is not yet established in humans, therefore
this study would evaluate the dynamics of different types of mononuclear cells and its
correlation with the therapeutic effect.
This clinical trial highlights the safety of using G-CSF in diabetic CLI by having a
separate control group in which volunteers would be given only G-CSF through subcutaneous
route, also this would tell about the therapeutic effect if any attributable to it.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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