Capsaicin 8% patch treatment in non-freezing cold injury (NFCI)

Phase 4

• Conditions: on-freezing cold injury, NFCI (Trench Foot).; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN11180128
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-02
• Last Update Posted: 12 February 2024
• Study Completion: 2026-08-07

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Military service personnel aged 18-60 years with non-freezing cold injury (NFCI) resulting in painful neuropathy
2. History of distal symmetric sensory polyneuropathy affecting feet for at least 8 weeks, confirmed on clinical examination and/or sensory testing and assessed on the 11-point pain intensity numerical pain rating scale (NPRS).
3. Patients with a history of pain intensity equal to or greater than 4 NPRS points are eligible to participate.
4. The use of systemic analgesics to relieve pain including anti-depressants, anticonvulsants, opioids, salicylates, paracetamol, and non-steroidal anti-inflammatory drugs (NSAIDs) will be permitted, providing any changes are recorded for the entire duration of the study

Exclusion Criteria

1. Participating in another clinical trial or who has done so within 30 days before screening
2. Additional medical condition or illness that, in the opinion of the Investigator, would interfere with study compliance and/or impair the patient's alcohol or drug abuse) within the previous six months before enrolment
3. A history of severe allergies or multiple drug allergies and/or reported hypersensitivity to capsaicin
4. Other conditions that may lead to neuropathic pain or hypersensitivity e.g. diabetes, and HIV
5. Topical anaesthetic or capsaicin applications, or history of previous treatment with the Capsaicin 8% patch (to minimise unblinding)
6. Pregnant or nursing mothers will not be included in this study; relevant history will be taken. A pregnancy test will be performed and patients who are pregnant will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured using a visual analogue score (VAS) at baseline (pre-treatment visit) and 3, 6, 9, and 12 months after the baseline visit (post-treatment follow-up visits)

Secondary Outcome Measures

Name	Time	Method
Changes in nerve markers showing nerve fibre density (with marker PGP9.5) and regeneration (with marker GAP-43) after application of Capsaicin 8% patch in skin biopsies at the site of the treatment measured using immunohistology at baseline (pre-treatment visit) and 3, 6, 9, 12 months after the initial baseline visit (post-treatment follow-up visits).