Atherosclerotic Ischemic Disease, Intermittent Claudication, PAD
Conditions
Brief summary
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months
Detailed description
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Pain free walking distance will be evaluated at the day of randomization, 1 , 3, 6 and 12 months by pedometer.
Interventions
PROCEDUREPB-MNC therapy
The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week
DRUGNo PB-MNC therapy
Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor who measure the pain free walking distance, ABI, TBI,TCOM do not know the result of randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic arterial occlusive disease who presented with intermittent claudication
Exclusion criteria
* Recent myocardial infarction * Severe valvular heart disease * After organ transplantation * Cardiomyopthy( EF\< 25%) * Liver failure * Coagulopathy * HIV * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain free walking distance | 3 month | the maximum distance which patient could walk without pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle brachial index (ABI) | 1,3,6,12 month | Ankle brachial indexThe Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD) |
| Toe brachial index (TBI) | 1,3,6,12 month | Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures |
| Transcutaneous oxygen measurement (TCOM) | 1,3,6,12 month | Transcutaneous oxygen measurement |
| 36-Item Short Form Health Survey (SF36) | 1,3,6,12 month | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. |
| Pain free walking distance | 1,6,12 month | the maximum distance which patient could walk without pain |
Countries
Thailand
Contacts
Primary ContactNuttawut Sermsathanasawadi, MD, PhD
Outcome results
None listed