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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14254122

Enrollment

Registered

2018-09-14

Start date

2018-08-02

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral neuropathy Nervous System Diseases Diabetic peripheral neuropathy

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026