Peripheral arterial disease - Critical Limb Ischemia (CLI) CLI is the end stage of peripheral arterial disease in the legs and is a onsequence of deteriorating blood flow supply to the lower limbs. The clinical definition of CLI includes peripheral arterial disease and recurrent rest pain since >two weeks with or without ulcers or gangrene. The prevalence in Sweden is 0.8% over 60. Patients with CLI face a high risk for amputation and have a low quality of life due to leg pain.
Conditions
Interventions
Trade Name: Lyrica
Product Name: Lyrica
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Rest pain, gangrene or ulcers located below the patella for a duration of at least two weeks (either one of these criteria are sufficient) 2. One measurement of: Ankle blood pressure(ABP) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age < 55 years 2. Women of childbearing potential 3. Patients already medicating with Pregabalin or Gabapentin 4. Creatinine clearance <30ml/min (Normogram assessment using serum creatinine and body weight is sufficient) 5. Amputation necessary within two weeks 6. Revascularization necessary within two weeks (open vascular surgery or endovascular) 7. A medical history of clear dizzness 8. NYHA class IV heart failure 9. Known hypotension, or having a systolic arm blood pressure <120 mm Hg (two consective measurements with the patient lying supine) 10. Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices 11. Mental condition making the subject unable to understand the concepts and risk of the study 12. Known allergies against pregabalin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate pregabalin as a potential analgetic in CLI ;Secondary Objective: none;Primary end point(s): rating scale pain after two weeks of treatment | — |
Countries
Sweden
Outcome results
None listed