CClinicalTrials.gg
Status unknownNCT01748422Updated Nov 11, 2016

Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

An observational study in Neuropathic Pain and Arteriovenous Fistulae, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-11-11.

Sponsored by NHS Greater Glasgow and Clyde · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neuropathic Pain
  • Arteriovenous Fistulae

Keywords

  • Neuropathic pain
  • Arteriovenous fistulae
  • End stage renal disease
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Experimental: Qutenza

    Single treatment with Qutenza (topical capsaicin8%) transdermal patch

    Drug: Qutenza

Interventions

  • DrugQutenza

    Transdermal patch

    Also known as: Topical capsaicin 8%

06

What researchers measure

Primary outcomes

  1. Neuropathic pain

    As assessed by Visual Analogue Pain Score

    Time frame: 12weeks

Secondary outcomes

  1. Neuropathic pain

    As assessed by Visual Analogue Pain Score and Brief Pain Inventory

    Time frame: 1 week, 6 weeks

  2. Quality of life

    As assessed by EQ-5D

    Time frame: 6 weeks, 12 weeks

  3. Safety and tolerability

    As assessed by: Number of adverse reactions.

    Time frame: 1 week, 6 weeks and 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Renal Surgery, Queen Elizabeth University Hospital
    Glasgow, Lanarkshire G51 4TF, United Kingdom
    • Marc Clancy, FRCS PhD · Contact · Marc.Clancy@ggc.scot.nhs.uk · 0141 451 6210
    • Patrick K Kearns, MBChB · Contact · Patrickkearns@nhs.net · 0141 452 2423
    • Patrick K Kearns, MBChB · Principal investigator
    • Emma L Aitken, MBChB · Sub investigator
    • Marc Clancy, MBChB · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01748422
Lead sponsor
NHS Greater Glasgow and Clyde
Responsible party
Dr Patrick Kearns (Principal Investigator, NHS Greater Glasgow and Clyde) — Principal investigator
First posted
Dec 12, 2012
Start date
Nov 2015
Primary completion
Aug 2017 (estimated)
Completion
Aug 2017 (estimated)
Last update
Nov 11, 2016

Study contacts

Marc Clancy, PhD FRCS
Contact
Marc.Clancy@ggc.scot.nhs.uk
0141 451 6210
Patrick K Kearns, MBChB
Contact
Patrickkearns@nhs.net
0141 451 6210
Patrick K Kearns, MBChB
principal investigator · NHS Greater Glasgow and Clyde
Marc Clancy, FRCS, PhD
principal investigator · NHS Greater Glasgow and Clyde

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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