Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients

NCT05461274 | Not Yet Recruiting

• 1 other identifier: 8874740
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Neuropathies; Diabetic Neuropathy Peripheral

Keywords

diabetic neuropathy; neuropathy

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in an diabetic neuropathy clinical trial

  3 months

• Rate of patients who remain in diabetic neuropathy clinical trial to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diabetic neuropathy who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related 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.

  PMID: 30545650 BACKGROUND

• 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.

  PMID: 7589838 BACKGROUND

• 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.

  PMID: 32036431 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12