Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Diabetic Neuropathy, sponsored by Endocrine Research Solutions.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
LEFS consists of 20 items, each scored on a 5-point scale (0 = extreme difficulty, 4 = no difficulty). Scoring: The maximum score is 80, with higher scores indicating better function. A lower score suggests greater disability or difficulty in performing daily activities. The MNSI has two parts- Part A: Self-administered questionnaire with 15 items about symptoms related to neuropathy. Scoring is based on the presence or absence of symptoms, with a higher score indicating more symptoms. Part B
Conditions Studied
Interventions
- DEVICE Semiconductor Embedded Therapeutic Socks
- DEVICE Placebo Socks
Study Locations (1)
Georgia
- Endocrine Research Solutions, Inc. - Roswell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2025-06 |
| Phase | NA |
What NCT06452914 shows while recruiting
NCT06452914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 174-participant average among 8 other Diabetic Neuropathy trials with a reported enrollment target (54% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetic Neuropathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06452914's enrollment target sits among peer trials
80 7th of 8 higher than 2 of 8 other Diabetic Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Neuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training
COMPLETED · NA
-
Long COVID-19 Cutaneous Signatures: An ARPA Funded Research Project
ACTIVE NOT RECRUITING
-
Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
COMPLETED · Phase 2
-
Study of DA-9801 to Treat Diabetic Neuropathy
COMPLETED · Phase 2
-
The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy
COMPLETED · Phase 2
-
A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI