Clinical trial NCT05461274: Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients
Official title: An In Depth Study Examining Patterns in the Clinical Trial Experiences of Diabetic Neuropathy Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Neuropathies
Diabetic Neuropathy Peripheral
Keywords: diabetic neuropathy
neuropathy
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who decide to enroll in an diabetic neuropathy clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in diabetic neuropathy clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.