Diabetic Neuropathies Clinical Trial
Official title:
An In Depth Study Examining Patterns in the Clinical Trial Experiences of Diabetic Neuropathy Patients
| NCT number | NCT05461274 |
| Other study ID # | 8874740 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2024 |
| Est. completion date | August 2026 |
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy. The data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient plans to participate in an interventional clinical trial for the condition of diabetic neuropathy - Patient has been diagnosed with a type of diabetic neuropathy - Patient is a minimum of 18 years of age - Patient has access to a home internet connection in order to provide regular updates through the course of the study Exclusion Criteria: - Patient is not able to provide consistent digital updates as per study requirements - Patient does not complete or agree to terms outlined in the Informed Consent Form - Patient has an ECOG score of 4 or higher |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
Clark LT, Watkins L, Pina IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G, Regnante JM. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019 May;44(5):148-172. doi: 10.1016/j.cpcardiol.2018.11.002. Epub 2018 Nov 9. Erratum In: Curr Probl Cardiol. 2021 Mar;46(3):100647. — View Citation
Pfeifer MA, Schumer MP. Clinical trials of diabetic neuropathy: past, present, and future. Diabetes. 1995 Dec;44(12):1355-61. doi: 10.2337/diab.44.12.1355. — View Citation
Rosenberger DC, Blechschmidt V, Timmerman H, Wolff A, Treede RD. Challenges of neuropathic pain: focus on diabetic neuropathy. J Neural Transm (Vienna). 2020 Apr;127(4):589-624. doi: 10.1007/s00702-020-02145-7. Epub 2020 Feb 8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who decide to enroll in an diabetic neuropathy clinical trial | 3 months | ||
| Primary | Rate of patients who remain in diabetic neuropathy clinical trial to trial completion | 12 months |
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