Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to the regular pain regimens for these patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborator: Karolinska University Hospital
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Rest pain, gangrene or ulcers located below the patella for a duration of at least two weeks (either one of these criteria are sufficient).

• One measurement of: Ankle blood pressure(ABP) <70 mm Hg, an toe blood pressure(TBP) <50, or a TcPO2<45 mm Hg, or an ankle/brachial pressure index <0.7 (either one of these criteria are sufficient).

• Informed consent obtained

Exclusion Criteria:

• Age < 55 years

• Women of childbearing potential

• Patients already medicating with Pregabalin or Gabapentin

• Creatinine clearance <30ml/min

• Amputation necessary within two weeks

• Revascularization necessary within two weeks (open vascular surgery or endovascular)

• A medical history of clear dizziness

• NYHA class IV heart failure

• Known hypotension, or having a systolic arm blood pressure <120 mm Hg (two consecutive measurements with the patient lying supine)

• Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices

• Mental condition making the subject unable to understand the concepts and risk of the study

• Known allergies against pregabalin