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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date December 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone (415) 900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

References & Publications (3)

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

Outcome

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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