Pregabalin for pain reduction in Critical Limb Ischemia

Conditions: 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.

Registration Number: EUCTR2005-004128-38-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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) <70 mm Hg, an toe blood pressure(TBP) <50, or a TcPO2<45 mm Hg, or an ABI<0.7
(either one of these criteria are sufficient)
3.Informed consent obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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