Diabetic painful neuropathy
Conditions
Interventions
Trade Name: Qutenza (Capsaicin) 8 % patch
Product Name: Qutenza (Capsaicin) 8 % patch
Pharmaceutical Form: Cutaneous patch
Sponsors
Joint Research Compliance Office, Imperial College London and Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 18-80 years with painful distal, symmetrical, sensorimotor polyneuropathy due to type 2 Diabetes of at least 1-year duration. 2. Stable control for at least 3 months of type 2 Diabetes mellitus. 3. Glycosylated haemoglobin (hbA1c) of = 9%. 4. Willing to provide written informed consent to participate in the study. 5. Patients with a history of pain intensity equal or greater than 4 NPRS points (as determined by the NPRS study diary at baseline) are eligible to participate. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Non-diabetic neuropathies 2. History of alcohol/substance abuse 3. History of severe psychiatric illnesses 4. Pregnancy/breast feeding or planning pregnancy during the course of the study 5. Significant renal impairment (eGFR <30mL/minute/1.73m2) 6. Heart failure New York Heart Association (NYHA) = class II 7. Any other painful medical conditions that may interfere with the assessment of change in neuropathic pain. In addition to the exclusion criteria above patients who are participating in another clinical trial or who have done so within 30 days before screening will be considered as not eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We propose to test, in patients with diabetes and chronic nerve pain, the effects of repeated applications of capsaicin 8% patch on pain, sensory tests, and the potential to repair the nerve fibre damage in serial skin punch biopsies. ;Secondary Objective: The secondary objectives of this study are to determine the effectiveness of repeated applications of capsaicin 8% patch in 1. Reducing areas of increased sensitivity or numbness in the skin, assessed using a) cotton wool, b) brush, c) monofilaments (nylon hairs), d) pinprick and e) temperature sensation; 2. Improvement of different pain characteristics using the McGill pain questionnaire; 3. Improving the Patient Global Impression of Change (PGIC). ;Primary end point(s): The outcome measures will include confirmation of overall reduction in mean NPRS pain score at the site of capsaicin 8% patch, and this will be related to skin biopsy markers, particularly PGP9.5 and GAP-43 density in the dermis, to assess nerve repair and regeneration (disease modification), which is the aim of this study.;Timepoint(s) of evaluation of this end point: 24 months(end of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sensory testing, patient global impression of change (PGIC).;Timepoint(s) of evaluation of this end point: 24 months(end of study). | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Praveen Anand
Imperial College London
Outcome results
None listed