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NCT06452914 · ClinicalTrials.gov registry record · NA

Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

A NA study of Diabetic Neuropathy, sponsored by Endocrine Research Solutions.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT06452914 is a NA study of Diabetic Neuropathy that is actively recruiting participants, run by Endocrine Research Solutions. The registered enrollment target is 80 participants, below the 174-participant average among 8 other Diabetic Neuropathy trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06452914, a NA study of Diabetic Neuropathy, is actively recruiting participants, sponsored by Endocrine Research Solutions.

RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

Distal symmetric polyneuropathy, also known as diabetic neuropathy, is the most common neurological complication of diabetes and a main cause of morbidity. The condition leads to gradual loss of function of the longest nerve fibers that limits function and decreases quality of life. Symptoms present distally and symmetrically in toes and feet. Symptoms of the neurologic disability include sensory loss, risk of foot ulcers and limb amputations and pain. The condition is not generally considered reversible, and condition management aims to slow progression and prevent complications. According to estimates from the International Diabetes Federation, diabetic neuropathy affected approximately 425 million people in 2017, with projections indicating a rise to 628 million by 2045. Despite the high prevalence of this condition, it is commonly misdiagnosed and has limited treatment options. There are multiple phenotypes of diabetic neuropathy, with the most common form being distal symmetric sensorimotor polyneuropathy, which is what we will be focusing on in this study. The proposed study seeks to evaluate the effectiveness of a non-compressive therapeutic socks throughout a 12-week course of rehabilitation for managing distal symmetric polyneuropathy. Outcome measures will be collected at standard intervals and compared with pre-treatment measures to evaluate effectiveness of treatment.

Conditions Studied

Interventions

  • DEVICE Semiconductor Embedded Therapeutic Socks
  • DEVICE Placebo Socks

Study Locations (1)

Georgia

  • Endocrine Research Solutions, Inc. - Roswell

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-06-11
Est. Completion 2025-06
Phase NA

Sponsor

Endocrine Research Solutions

1 total trials

What the Registry Record Tells You About NCT06452914

The ClinicalTrials.gov registry entry for NCT06452914 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 174-participant average among 8 other Diabetic Neuropathy trials with a reported enrollment target (54% lower). The listed sponsor is Endocrine Research Solutions, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Semiconductor Embedded Therapeutic Socks is the first listed.

NCT06452914 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT06452914 about?

NCT06452914 is a clinical study titled "Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks". Distal symmetric polyneuropathy, also known as diabetic neuropathy, is the most common neurological complication of diabetes and a main cause of morbidity. The condition leads to gradual loss of function of the longest nerve fibers that limits function and decreases quality of life. Symptoms present...

What is the current status of trial NCT06452914?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2024-06-11. Estimated completion is 2025-06.

What conditions does trial NCT06452914 study?

This clinical trial studies the following conditions: Diabetic Neuropathy.

What interventions are being tested in trial NCT06452914?

The interventions under investigation include: Semiconductor Embedded Therapeutic Socks (DEVICE), Placebo Socks (DEVICE).

Who is sponsoring clinical trial NCT06452914?

This trial is sponsored by Endocrine Research Solutions, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06452914 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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