Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05461274
Collaborator
(none)
500
24

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    An In Depth Study Examining Patterns in the Clinical Trial Experiences of Diabetic Neuropathy Patients
    Anticipated Study Start Date :
    Aug 13, 2022
    Anticipated Primary Completion Date :
    Aug 13, 2023
    Anticipated Study Completion Date :
    Aug 13, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who decide to enroll in an diabetic neuropathy clinical trial [3 months]

    2. Rate of patients who remain in diabetic neuropathy clinical trial to trial completion [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05461274
    Other Study ID Numbers:
    • 8874740
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022