Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
PAD is caused by an increased flow resistance in atherosclerotic ischemic limbs. The
 investigators hypothesize that reducing blood viscosity (through controlled phlebotomy),
 thereby increasing the deformability of red blood cells, should reduce the flow resistance
 and improve tissue perfusion leading to improved clinical function and a reduction in
 symptoms.

 Preliminary data demonstrates that phlebotomy causes a measurable change in blood viscosity
 as measured by the home-made rheologic method.

 To evaluate the effectiveness of changes in blood viscosity, obtained through controlled
 phlebotomy, as a therapy to improve functional status associated with atherosclerotic
 ischemic limbs in pre-amputation patients.
The first study is a pilot study and will act as proof of principle. This first study will
 include 20 patients divided into 2 groups on the basis of a randomized controlled trial: 10
 patients in the control group receiving conventional treatment and 10 patients receiving
 therapeutic phlebotomy to lower blood viscosity. The objective is to evaluate the effect of
 controlled phlebotomy in patients with Grade 3, Category 5 or 6 chronic critical limb
 ischemia having tissue loss on Rutherford classification (Fontaine stage IV), end-stage
 peripheral vascular disease resistant to maximal medical therapy and where revascularization
 therapy (both percutaneous and surgical) has either proved insufficient or is
 contra-indicated or declined by the patient, usually resulting in amputation.

 The primary outcome parameters will be: the salvage rate of the limb as compared with the
 salvage rate of the limb with conventional therapy.

 Objective classification of improvement in perfusion of the distal extremities using
 ankle-brachial index (ABI), visual analogue pain scale, and photos.

 Subjective classification of improvement in pain scale on critical limbs.

 The relationship between alteration in outcome parameters (i.e., the end point is a reduced
 amputation rate) and blood viscosity will be evaluated as measured by the home-made rheologic
 methods.
Inclusion Criteria:

 -  Subjects should have diagnosed Rutherford classification Grade 3, Category 5 or 6
 (Fontaine stage IV) treatment-resistant chronic critical limb ischemia having tissue
 loss, not relieved by maximal medical therapy and they should have exhausted or not be
 candidates for surgical (other than heart transplant) or percutaneous intervention

 -  Male

 -  Age: 18 to 80 years

 -  Current non-smokers

 -  BMI >19

 -  Estimated 6 month survival rate >90%

 -  Concomitant stable medications will be allowed.

 -  If the subjects have coronary artery disease established by history, angina pain, EKG,
 Lab including Troponin I, creatine kinase, lactate dehydrogenase, Echocardiography,
 Thallium scan or coronary angiography, the subjects should have established a
 classification of coronary artery involvement by coronary angiography or other
 procedure with similar precision.

 Exclusion Criteria:

 -  Anemia

 -  Low blood pressure (systolic < 120 mmHg)

 -  Baseline hematocrit < 30

 -  Initial whole blood viscosity measurements below 15 miliPoiseille