Qutenza for Critical Ischaemia in End Stage Renal Failure

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being delivered to the tissues. It normally affects the hands and feet and can be very debilitating. It is particularly common and difficult to treat in patients with end stage renal failure

Patients with renal failure are often high risk of any operative intervention which might help the pain. Often the only treatment options are painkillers. Unfortunately however, the commonly used painkillers, for example morphine, are known to cause worse side effects in patients with renal failure (drowsiness, confusion etc.

Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before.

We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and painful ischaemia. We will recruit 20 patients with painful ischaemia and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.

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

Details

• Lead Sponsor: Emma Aitken
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

• All adult patients > 18 years old with end stage renal disease on dialysis and critical ischaemia defined as rest pain most days for >3 months

Exclusion Criteria:

• Pre-dialysis

• Hypersensitivity to Qutenza, Emla or any of the excipients

• Broken skin or active ulceration at the site of application

• Severe uncontrolled hypertension (systolic BP >200)

• Proven cardiac event during the preceding 3 months

• Women who are pregnant or breast feeding

• Diabetic neuropathy resulting in a loss of sensation

• Lack of capacity or inability to provide informed consent

• Declines participation in the study