Condition category
Nervous System Diseases
Date applied
24/08/2018
Date assigned
14/09/2018
Last edited
14/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
p.anand@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Praveen Anand

ORCID ID

Contact details

Area A
Ground Floor
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

2017-004746-17

ClinicalTrials.gov number

Protocol/serial number

17HH4283

Study information

Scientific title

Pain relief with disease modification by Capsaicin 8% patch: a clinical study in diabetic peripheral neuropathy.

Acronym

Capsaicin pain patch.

Study hypothesis

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.

Ethics approval

East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 02/01/2018, REC reference number: 17/EE/0498

Study design

Interventional longitudinal randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Diabetic peripheral neuropathy

Intervention

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.

Intervention type

Drug

Phase

Phase IV

Drug names

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

01/01/2018

Overall trial end date

02/10/2020

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Other painful medical conditions
2. Significant renal impairment
3. Heart failure

Recruitment start date

02/08/2018

Recruitment end date

02/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Peripheral Neuropathy Unit, Imperial College London, Hammersmith Hospital, Du Cane Rd
London
W12 ONN
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Ms Gisela Barreto
Joint Research Compliance Office
Room 221
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom

Sponsor type

University/education

Website

https://www.imperial.ac.uk/

Funders

Funder type

Not defined

Funder name

Diabetes UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/10/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes