Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT04593992
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2020-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HTEMS Treatment of Diabetic Polyneuropathy
Sponsor:
West German Center of Diabetes and Health
Organization:
Study Overview
Official Title:
High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HTEMS-RCT
Brief Summary:
So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.
Detailed Description:
Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: