The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy

• Status: Completed
• Trial end date: 2020-01-02
• Target enrollment: 0
• Participant gender: Male

Summary

The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corporacion Parc Tauli
• Treatments: Capsaicin; Lidocaine

Criteria

Inclusion Criteria:

• Males aged 40 - 60

• Type 2 diabetes of >10 years duration

• Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1)

Exclusion Criteria:

• Diabetic foot ulcer

• Deformed or contracted foot

• Neurological complications

• Presence of neurological disease

• Presence of cardiovascular or peripheral vascular disease,

• Usage of topical analgesics or implanted medical device six weeks prior to the study