Evidence mapPaperPMID 40316314Full record

ArticleBMJ open diabetes research & care2025

CASPAR: a retrospective cohort study of the high-concentration capsaicin topical system in patients with painful diabetic peripheral neuropathy of the feet.

Michael Überall, Tamara Quandel, Sylvia Engelen, Lucia Garcia-Guerra, Tawfik Fajri, Samuel Allen, Rita Freitas, Zoltan Kender, Marielle Eerdekens

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Article in BMJ open diabetes research & care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Michael ÜberallInstitute of Neurological Sciences, Nürnberg, Germany.
Tamara QuandelGrünenthal GMBH, Aachen, Germany.
Sylvia EngelenGrünenthal GMBH, Aachen, Germany.
Lucia Garcia-GuerraGrünenthal Pharma SA, Madrid, Spain.
Tawfik FajriLaboratoires Grünenthal SAS, Paris, France.
Samuel AllenAveritas Pharma, Morristown, New Jersey, USA.
Rita FreitasGrünenthal SA, Lisbon, Portugal.
Zoltan KenderDepartment for Endocrinology, Diabetology, Metabolic Diseases and Clinical Chemistry, University Hospital Heidelberg, Heidelberg, Germany.
Marielle EerdekensGrünenthal GMBH, Aachen, Germany marielle.eerdekens@grunenthal.com.ORCID http://orcid.org/0000-0001-6198-4806

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPainful diabetic peripheral neuropathy (pDPN), a common complication of diabetes, is challenging to treat and negatively impacts quality of life (QoL). Many patients either fail to achieve adequate pain relief with current treatments or suffer from systemic side effects with oral options. This study used data from the German Pain e-Registry (GPeR) to evaluate the high-concentration capsaicin topical system (HCCTS) for treating pDPN of the feet. RESEARCH DESIGN AND

methodsThis retrospective, non-interventional cohort study (CASPAR) included patients with pDPN of the feet who received ≥1 HCCTS treatment (~3-month treatment intervals) and contributed data to the GPeR for ≥12 months. Data were collected on pain intensity, QoL, sleep, mood, concomitant medication, and tolerability.

resultsOverall, 365 patients with pDPN of the feet were included. Significant reductions in 24-hour average pain intensity (API) were observed from baseline to month 3 (following one HCCTS treatment). Further reductions in mean API score were seen over 12 months with ongoing treatments, whereas API increased in patients who discontinued treatment (baseline to month 12 mean API scores: 61.4 to 8.8 for four HCCTS [∆ -52.6], 59.3 to 16.7 for three HCCTS [∆ -42.6], 56.3 to 31.9 for two HCCTS [∆ -24.4], 57.5 to 51.4 for one HCCTS [∆ -6.1]). Similar trends were seen for sleep, mood, and QoL outcomes. There was a significant reduction in concomitant pain medication use in patients receiving ongoing HCCTS treatments. The most common adverse events were local application-site reactions.

conclusionsThis real-world study in patients with pDPN of the feet demonstrates that ongoing HCCTS treatments continue to improve pain intensity, mood, and QoL, while concomitant medication use decreases. Benefits from treatment were lost following HCCTS discontinuation. These findings emphasize the importance of ongoing treatments to achieve the potential of HCCTS in improving outcomes for patients with pDPN.

Indexed as

CapsaicinDiabetic NeuropathiesSensory System AgentsAdministration, TopicalAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPain ManagementPain MeasurementPrognosisQuality of LifeRetrospective StudiesTreatment OutcomeCapsaicinSensory System AgentsCapsaicinDiabetic NeuropathiesFootRegistries

Identifiers

PMID40316314
PMCPMC12049874

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.