Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients

NCT ID: NCT05461274

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Neuropathies Diabetic Neuropathy Peripheral

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

References

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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.

Reference Type BACKGROUND
PMID: 30545650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7589838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32036431 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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8874740

Identifier Type: -

Identifier Source: org_study_id

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