Status:
TERMINATED
Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska University Hospital
Conditions:
Critical Limb Ischemia
Arterial Occlusive Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 pa...
Detailed Description
Critical limb ischemia (CLI) is the end stage of peripheral arterial disease in the legs and is a consequence of deteriorating blood flow supply to the lower limbs. The clinical definition of CLI incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00403780
Start Date
June 1 2006
End Date
July 1 2015
Last Update
June 15 2018
Active Locations (3)
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1
Deptartment of Vascular Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden
2
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
3
Deptartment of Surgery, South Hospital
Stockholm, Sweden