Atherosclerotic Ischemic Disease, Critical Limb Ischemia, PAD
Conditions
Brief summary
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,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 no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. 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. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.
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 wound care and pain killer drug
DRUGNo-PB-MNC therapy
Patients will receive ASA 81 mg once daily and wound care and pain killer drug
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months
Exclusion criteria
* Recent myocardial infarction * Severe valvular heart disease * After organ transplantation * Cardiomyopthy( EF\< 25%) * Liver failure * Coagulopathy * HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amputation free survival | 3 month | Rate of non amputated limb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amputation free survival | 1,6,12 month | Rate of non amputated limb |
| 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. |
Countries
Thailand
Contacts
Primary ContactNuttawut SERMSATHANASAWADI
Outcome results
None listed