Evaluating the effectiveness of capsaicin cream in patients with type 2 diabetes and diabetic peripheral neuropathy in the feet.

An 8-week, open-label, trial to evaluate the safety and efficacy of topical capsaicin 0.075% cream in adult patients with type 2 diabetes experiencing pain due to Diabetic Peripheral Neuropathy (DPN) in the feet - CAPTAIN-DPN

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101113

Enrollment

100

Registered

2026-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Capsaicin Cream: Capsaicin is used to help relieve a certain type of pain known as neuralgia (shooting or burning pain in the nerves) Intervention period is of 8 weeks Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes. HbA1c lesser than equal to 10 %. Age 18 to 75 years (inclusive of both) A history of Diabetic Peripheral Neuropathic (DPN) pain for at least 6 months. Average daily pain score greater than or equal to 4 on 11-point NRS (Numeric Rating Scale). On stable anti-diabetic medications for 3 months prior to screening.

Exclusion criteria

Exclusion criteria: Other chronic pain conditions not associated with DPN that may confound the assessment of pain in DPN. Osteoarthritis, history of gout in the last 3 years or lower extremity pain of any severity caused by current fibromyalgia, bursitis or fasciitis. Focal neuropathy in the lower extremities including nerve entrapment or local trauma. Active diabetic foot ulcer. Participant who are currently taking opioids for their painful DPN.

Design outcomes

Primary

Measure	Time frame
To evaluate change from baseline to week 8 in pain due to diabetic peripheral neuropathy (DPN) measured by an 11-point Numeric Rating Scale (NRS-11) in the feet of patients treated with topical capsaicin 0.075%.Timepoint: 8 weeks	—

Secondary

Measure	Time frame
To characterise the safety and tolerability of topical capsaicin 0.075% over 8 weeksTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr S Poongothai

Madras Diabetes Research Foundation

drmohans@diabetes.ind.in04443968888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026