The Capsaicin 8% patch for pain relief in diabetic peripheral neuropathy
| ISRCTN | ISRCTN14254122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14254122 |
| EudraCT/CTIS number | 2017-004746-17 |
| Secondary identifying numbers | 17HH4283 |
- Submission date
- 24/08/2018
- Registration date
- 14/09/2018
- Last edited
- 11/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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 November 2021
Who is funding the study?
Diabetes UK (UK)
Who is the main contact?
Professor Praveen Anand
p.anand@imperial.ac.uk
Contact information
Scientific
Area A, Ground Floor, Hammersmith Hospital, Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Study design | Interventional longitudinal randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Pain relief with disease modification by Capsaicin 8% patch: a clinical study in diabetic peripheral neuropathy. |
| Study 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(s) | East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 02/01/2018, REC reference number: 17/EE/0498 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2018 |
| Overall study end date | 11/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| 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 exclusion criteria | 1. Other painful medical conditions 2. Significant renal impairment 3. Heart failure |
| Recruitment start date | 02/08/2018 |
| Recruitment end date | 07/04/2021 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Du Cane Rd
London
W12 ONN
United Kingdom
Sponsor information
University/education
Ms Gisela Barreto
Joint Research Compliance Office
Room 221
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Website | https://www.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 26/10/2022 | 11/10/2023 | Yes | No |
Editorial Notes
11/10/2023: Publication reference added.
08/08/2022: The intention to publish date was changed from 01/08/2022 to 01/12/2022.
08/03/2022: The intention to publish date was changed from 01/03/2022 to 01/08/2022.
08/11/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 05/09/2019 to 07/04/2021.
2. The overall trial end date was changed from 02/10/2020 to 11/11/2021.
3. The intention to publish date was changed from 01/10/2020 to 01/03/2022.
12/06/2020: The following changes have been made:
1. The recruitment end date has been changed from 02/08/2020 to 05/09/2019.
2. The final enrolment number has been added
