Plain English Summary
Background and study aims
The current treatments for painful diabetic peripheral neuropathy (nerve damage caused by diabetes) have limited efficacy, and many significant side effects. There are no approved treatments to prevent or modify the progression of nerve damage. However, the capsaicin 8% patch, a skin plaster, is a new effective, safe and well-tolerated treatment for painful diabetic peripheral neuropathy. When used for 30 minutes as a single application, it can provide pain relief for 3 months and longer. This study aims to look at whether repeated applications of the capsaicin 8% patch can not only reduce pain but also prevent or modify the underlying nerve damage.
Who can participate in this study?
Patients who have had painful diabetic peripheral neuropathy for at least 1 year and have an average daily pain score of ≥4/10 on the Numerical Pain Rating scale
What does the study involve?
Patients will be randomly allocated to one of two groups - either the intervention group or the control group. Both groups will receive their usual treatment; however, the intervention group will also receive Capsaicin 8% patch treatment for 30 minutes every 12 weeks over a 12 month period. Patients in both groups will receive various tests at 12 week intervals, including skin biopsies.
What are the possible benefits and risks of participating?
The possible benefits of participating in this study may include a reduction in pain and other sensory symptoms. There are no known risks to participants taking part in this study.
Where is the study run from?
Hammersmith Hospital, London (UK)
When is the study starting and how long is it expected to run for?
January 2018 to October 2020
Who is funding the study?
Diabetes UK (UK)
Who is the main contact?
Professor Praveen Anand
Pain relief with disease modification by Capsaicin 8% patch: a clinical study in diabetic peripheral neuropathy.
Capsaicin pain patch.
The aim of this study is to investigate whether repeated treatments with the capsaicin 8% patch reduce the nerve pain and help the damaged nerve fibres to regrow normally.
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 02/01/2018, REC reference number: 17/EE/0498
Interventional longitudinal randomised parallel trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Diabetic peripheral neuropathy
Eligible patients will be randomised 2:1 to receive either the Capsaicin 8% patch and the usual Standard Of Care (SOC) (intervention group) or SOC alone (control group). Randomisation for the 2 groups will be via the hospital pharmacy. Patients in the intervention group will receive applications of Capsaicin 8% patch for 30 minutes to the feet at each visit. Visits will be every 12 weeks for a 12 month period, as licensed. Patients in the control group will continue to take their usual medication, as part of their standard of care. Patients in both groups will be assessed with bedside sensory tests and skin biopsy at 3, 6, 9 and 12 months.
Capsaicin 8% patch (Qutenza 179 mg cutaneous patch)
Primary outcome measure
Reduction in pain, assessed using the Visual Analogue Scale (VAS) at the baseline and at the end of the study
Secondary outcome measures
Changes in description of quality and nature of pain, assessed at the baseline and the end of the study using the following:
1. Modified version of the Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)
2. Patient Global Impression of Change (PGIC)
3. Change in area of pain or numbness, assessed using bedside sensory tests
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Painful distal, symmetrical, sensorimotor polyneuropathy due to diabetes of at least 1 year duration
2. Average daily pain score of ≥4/10 for painful diabetic neuropathy
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Other painful medical conditions
2. Significant renal impairment
3. Heart failure
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Peripheral Neuropathy Unit, Imperial College London, Hammersmith Hospital, Du Cane Rd
Imperial College London
Ms Gisela Barreto
Joint Research Compliance Office
Medical School Building
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
We aim to report and disseminate the results of the study in peer reviewed scientific journals and conference presentation.
IPD sharing statement:
Pseudonymised data will be stored within the department on a secure University computer in accordance with Imperial College policy. Only researchers involved in the study will have access to these data. During the overall duration of the study medical records and the data collected for the study may also be looked at by authorised people from the Sponsor or NHS Trust, to check that the study is being carried out correctly. All will have a duty of confidentiality to the research participant and will do their best to meet this duty. By signing the consent form, patients authorise the release of, or access to, this confidential information to the relevant study personnel and regulatory authorities as noted above.
Intention to publish date
Participant level data
Basic results (scientific)