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A randomized, double-blind, placebo-controlled study to assess the effects of high concentration capsaicin patch (Qutenza) on neuropathic symptoms, nerve fibers, and microcirculation in painful diabetic peripheral neuropathy
EU CTIS ID: 2025-523597-17-00
What this study is testing
To evaluate the efficacy of repeated treatment with capsaicin 8% cutaneous patch compared to placebo on skin innervation
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent signed and dated
- Willingness to maintain current analgesic treatment unchanged during the course of the study
- Ability and willingness to meet the study center visits and to undergo study procedures during the whole study duration
- If applicable, willingness to take acceptable contraceptive measures by female participants in childbearing potential during the treatment phase
- If applicable, negative urine pregnancy test by female participants in childbearing potential at screening
- Diabetes mellitus according to the American Diabetes Association criteria (2017), lasting ≥1 year
You likely can't join if
- Presence of pain caused by other conditions not clearly differentiated from pDPN as judged by the investigator
- Intraepidermal nerve fiber density at screening <1 fiber/mm
- Treatment with coumarins or heparin in a therapeutic dose or other contraindications against obtaining skin biopsies at the distal calf
- Pregnant women or nursing mothers
- Participation in another clinical trial study within the last 3 months prior to screening
- Neoplasms, except for basal cell carcinoma (basalioma) or low-grade prostate cancer within 12 months prior to screening
See the full eligibility criteria
Who can join
- Written informed consent signed and dated
- Willingness to maintain current analgesic treatment unchanged during the course of the study
- Ability and willingness to meet the study center visits and to undergo study procedures during the whole study duration
- If applicable, willingness to take acceptable contraceptive measures by female participants in childbearing potential during the treatment phase
- If applicable, negative urine pregnancy test by female participants in childbearing potential at screening
- Diabetes mellitus according to the American Diabetes Association criteria (2017), lasting ≥1 year
- Age: 18-80 years
- Presence of painful diabetic sensorimotor polyneuropathy (DSPN) as judged by the investigator lasting ≥6 months
- Presence of pain in the feet and/or ankle caused by painful DSPN as diagnosed by the investigator with an average or maximum NPRS of ≥4 points within 7 days before screening
- Presence of dysesthesia or paresthesia in the lower extremity caused by DSPN as diagnosed by the investigator lasting ≥6 months
- Presence of either i) neuropathic deficits in the lower extremity (reduced or absent achilles tendon reflexes, vibration sensation, temperature detection, pain perception, pressure sensation), ii) ≥1 abnormal nerve conduction study parameter in lower extremity peripheral nerves (reduced or not evoked peroneal or tibial motor nerve conduction velocity or sural sensory nerve conduction velocity or amplitude), iii) ≥1 abnormal quantitative sensory test at the lower extremity (temperature detection threshold, vibration perception threshold), or iv) reduced intraepidermal nerve fiber density at screening
- HbA1c <10% at screening
- If applicable, stable regimen of glucose-lowering and analgesic treatment for DSPN within 4 weeks prior to screening as judged by the investigator
What rules you out
- Presence of pain caused by other conditions not clearly differentiated from pDPN as judged by the investigator
- Intraepidermal nerve fiber density at screening <1 fiber/mm
- Treatment with coumarins or heparin in a therapeutic dose or other contraindications against obtaining skin biopsies at the distal calf
- Pregnant women or nursing mothers
- Participation in another clinical trial study within the last 3 months prior to screening
- Neoplasms, except for basal cell carcinoma (basalioma) or low-grade prostate cancer within 12 months prior to screening
- Currently active or history of alcohol use disorder (>24 units of alcohol per week) or other substance-use disorders as judged by the investigator within the last 5 years
- Uncontrolled high blood pressure (DBP >95 mmHg and/or SBP >160 mmHg), unless clearly documented to be white-coat hypertension, at screening
- Severe resting tachycardia (HR >110 bpm) at screening
- Mental, psychiatric or other conditions compromising data collection or understanding of written or oral instructions during the study
- Conditions that might interfere with the assessment of pDPN as judged by the investigator
- History of foot ulcers within the last 6 months prior to screening
- History of amputations at the lower extremity excluding minor amputations due to traumatic events not related to diabetic foot syndrome
- Treatment with Capsaicin 179 mg/8% patch within the last 6 months prior to screening or with any other topical analgesic pain treatment on the areas affected by neuropathic pain due to painful DSPN within the last 3 months prior to screening.
- Concomitant analgesic treatment for painful DSPN with more than two substances, with medium or high potency opioids, or with electrical stimulation within the last 3 months prior to screening.
- Substantial change in analgesic treatment regimen during the study as judged by the investigator
- Contraindications, known allergy, or hypersensitivity to capsaicin or other ingredients of the study medication or local anesthetics
- Average daily pain level ≥9 points NPRS within 7 days before screening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.