The Capsaicin 8% patch for pain relief in diabetic peripheral neuropathy

Phase 4

Completed

• Conditions: Diabetic peripheral neuropathy; Nervous System Diseases

• Registration Number: ISRCTN14254122
• Lead Sponsor: Imperial College London

Brief Summary

2022 Results article in https://doi.org/10.3389/fneur.2022.998904 (added 11/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-14
• Study Completion: 2021-11-11
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in pain, assessed using the Visual Analogue Scale (VAS) at the baseline and at the end of the study

Secondary Outcome Measures

Name	Time	Method
<br> Changes in description of quality and nature of pain, assessed at the baseline and the end of the study using the following:<br> 1. Modified version of the Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)<br> 2. Patient Global Impression of Change (PGIC)<br> 3. Change in area of pain or numbness, assessed using bedside sensory tests<br>