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

Last updated: June 13, 2018
Sponsor: Karolinska Institutet
Overall Status: Terminated

Phase

4

Condition

Pain

Peripheral Arterial Disease (Pad)

Peripheral Vascular Disease

Treatment

N/A

Clinical Study ID

NCT00403780
PREPARED_00
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Rest pain, gangrene or ulcers located below the patella for a duration of at least twoweeks (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 ofthese criteria are sufficient).

  • Informed consent obtained

Exclusion

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 consecutivemeasurements with the patient lying supine)

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

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

  • Known allergies against pregabalin

Study Design

Total Participants: 18
Study Start date:
June 01, 2006
Estimated Completion Date:
July 31, 2015

Study 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 includes peripheral arterial disease and recurrent rest pain for at least two weeks with or without ulcers or gangrene.

In patients not amenable to revascularization - around 35% - amputation or palliative conservative care remains the options. Pain control is a vital part of any treatment of these patients. Besides being the principal conservative treatment, also patients undergoing revascularization experience severe pain both during work up and after surgery.

Experimental data indicate that pain in CLI is multimodal and to a large extent neuropathic. Still, current therapy is mostly based on opioid treatment, which clinically often affects pain moderately. The doses required to influence pain are also associated to severe side effects. Accordingly, there is a great need to improve pain control in the rather common disease CLI.

comparisons: pregabalin up to 600mg daily in addition to regular pain regimens compared to placebo and regular pain regimens.

Connect with a study center

  • Deptartment of Vascular Surgery, Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

  • Department of Vascular Surgery, Karolinska University Hospital

    Stockholm, SE-171 76
    Sweden

    Site Not Available

  • Deptartment of Surgery, South Hospital

    Stockholm,
    Sweden

    Site Not Available

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