Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure

Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant 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 chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain; Arteriovenous Fistulae
• Intervention / Treatment: Drug: Qutenza

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Marc Clancy, PhD FRCS; Phone Number: 0141 451 6210; Email: Marc.Clancy@ggc.scot.nhs.uk
• Study Contact Backup: Name: Patrick K Kearns, MBChB; Phone Number: 0141 451 6210; Email: Patrickkearns@nhs.net

Study Locations

• United Kingdom
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G51 4TF
      • Recruiting
      • Department of Renal Surgery, Queen Elizabeth University Hospital
      • Contact: Marc Clancy, FRCS PhD; Phone Number: 0141 451 6210; Email: Marc.Clancy@ggc.scot.nhs.uk
      • Contact: Patrick K Kearns, MBChB; Phone Number: 0141 452 2423; Email: Patrickkearns@nhs.net
      • Principal Investigator: Patrick K Kearns, MBChB
      • Principal Investigator: Marc Clancy, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae

Description

Inclusion Criteria:

• All adult patients >18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)

Exclusion Criteria:

• Pre-dialysis
• Underlying anatomical/ structural abnormality with AVF contributing to pain
• Diabetic neuropathy resulting in sensory loss
• 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
• Lack of capacity or inability to provide informed consent
• Declines participation in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: Qutenza; Single treatment with Qutenza (topical capsaicin8%) transdermal patch	Drug: Qutenza; Transdermal patch; Other Names: Topical capsaicin 8%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain	As assessed by Visual Analogue Pain Score	12weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain	As assessed by Visual Analogue Pain Score and Brief Pain Inventory	1 week, 6 weeks
Quality of life	As assessed by EQ-5D	6 weeks, 12 weeks
Safety and tolerability	As assessed by: Number of adverse reactions.	1 week, 6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Patrick K Kearns, MBChB, NHS Greater Glasgow and Clyde; Principal Investigator: Marc Clancy, FRCS, PhD, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 9, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Neuropathic pain; End stage renal disease; Arteriovenous fistulae
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Congenital Abnormalities; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Neuralgia; Fistula; Arteriovenous Fistula; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: GU11SB126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided