A clinical trial to evaluate the effect of bone marrow derived stem cell in diseases Limb Ischemia
- Conditions
- Health Condition 1: null- Limb Ischemia
- Registration Number
- CTRI/2010/091/000565
- Lead Sponsor
- Department of Biotechnology New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1)Clinical
a)Rest pain requiring analgesia for > 2 weeks, and/or non healing ischemic ulcers
b)Absent /weak peripheral pulses
c)No response to smoking cessation for at least 3 months prior to evaluation
d)Not suited for surgical/ endovascular revascularization
d)Unilateral or bilateral involvement
e) Claudication distance of <200 meters.
2) Hemodynamic
a) Doppler study showing an occluded superficial femoral, popliteal, or infra-popliteal artery, with no or poor distal flow as evidenced by a monophasic, low velocity, collateralized flow pattern.
b) Contrast-enhanced magnetic resonance and digital subtraction angiography demonstrating the site of occlusion, status of distal run-off and the extent of collateralization
c) Ankle systolic pressure < 50 mm Hg
d) A resting ankle brachial pressure index <0.5 in the affected limb on 2 consecutive examinations done at least 2 days apart (normal range, 0.9-1.1).
a)Poorly controlled diabetes mellitus
b)Evidence of a malignancy during the last 5 year
c)Renal dysfunction or other contraindication to injection of contrast media
d)Continued smoking
e)Limitation to exercise due to any reason other than claudication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the composite of clinical status and improvement in TcO2 and improvement in ABITimepoint: 1, 3 and 6 month
- Secondary Outcome Measures
Name Time Method Improvement in the grade of collaterals or Improvement in the visualization of distal run-off vesselsTimepoint: 1, 3 and 6 month