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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non phlebotomy group (control group) | No Intervention | • This control group is the patients who had Rutherford classification Grade 3, Category 5 or 6 (Fontaine stage IV) treatment-resistant chronic critical limb ischemia having tissue loss. They were treated with conventional standard treatment including revascularization operative procedure if feasible, maximum medical treatment with anticoagulation (heparin, low molecular weight heparin, etc), acetylsalicylic acid, cilostazol, and prostaglandin E1, dextran, and pain analgesia with opioid, and finally major amputation. We records all control arms' amputation, day to amputation, mortality, etc. We will compare amputation and mortality between control and treatment groups. Non phlebotomy arm has no phlebotomy treatment. | |
| PH (study group) | Experimental | The patients will be pre-amputation and have Rutherford classification Grade 3, Category 5 or 6 (Fontaine stage IV) treatment-resistant chronic critical limb ischemia having tissue loss. Procedures for therapeutic phlebotomy
They were treated both phlebotomy and conventional standard management including surgery, medication, amputation, etc. We will compare amputation and mortality between control and study groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phlebotomy | Procedure | repeated phlebotomy for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major amputation rate (limb salvage rate) | The rate of lower limb major amputation (limb salvage rate) was measured in both study arms, during 5 year follow-up period. They would be the evidences of phlebotomy treatment directly. | 5 year follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-major amputation | During 5 year follow-up period, we measured the time-to-major amputation between the two groups, phlebotomy study group and control group. They would be the evidences of phlebotomy treatment directly. | 5 year follow-up period |
| Mortality rate |
| Measure | Description | Time Frame |
|---|---|---|
| VA pain scale | After 4 weeks phlebotomy, we measured and confirmed the VA pain scale improvement or not in study group. They would be the evidences of phlebotomy treatment indirectly. | Conducting study periods (4 weeks) |
| Ankle-Brachial Index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doosang Kim, M.D.,Ph.D. | Seoul Veterans Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Veterans Hospital | Seoul | 134-060 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2018 | |
| Reset | Nov 19, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2018 | Nov 19, 2018 |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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During 5 year follow-up period, we measured the mortality rate as a final result of a treatment and major amputation between the two groups, phlebotomy study group and control group. They would be the evidences of phlebotomy treatment directly. |
| 5 year follow-up period |
| Blood viscosity measurements | 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. Evaluate blood viscosity measurements with the home-made rheologic method as a monitor of and marker for the clinical effectiveness of therapeutic phlebotomy in patients with Rutherford classification Grade 3, Category 5 or 6 (Fontaine stage IV) treatment-resistant chronic critical limb ischemia having tissue loss. | Conducting study periods (4 weeks) |
After 4 weeks phlebotomy, we measured and confirmed the ABI improvement or not in study group. They would be the evidences of phlebotomy treatment indirectly.
| Conducting study periods (4 weeks) |
| Complete wound healing | After 4 weeks phlebotomy, we measured and confirmed the complete wound healing (no more discharge from wound and complete epithelialization) between two groups. They would be the evidences of phlebotomy treatment directly. | Conducting study periods (4 weeks) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |