Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
TerminatedPhase 4NCT00403780
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study
- Conditions
- Critical Limb Ischemia
- Arterial Occlusive Disease
- Pain
- Ischemia
- Interventions
- Sponsor
- Karolinska Institutet
- Collaborators
- Karolinska University Hospital
- Start date
- 2006-06
- Primary completion
- 2013-05
- Sex
- All
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00403780