Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-14 @ 1:56 AM
Study NCT ID:
NCT01175928
Status:
UNKNOWN
Last Update Posted:
2012-04-20
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy
Sponsor:
NormaTec Industries LP
Organization:
Study Overview
Official Title:
Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy
Status:
UNKNOWN
Status Verified Date:
2012-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the treatment of Diabetic Peripheral Neuropathy (DPN).
The study will compare treatment with a NormaTec PCD and a sham device to assess whether the NormaTec PCD improves the signs and symptoms of DPN.
The study will compare treatment with a NormaTec PCD and a sham device to assess whether the NormaTec PCD improves the signs and symptoms of DPN.
Detailed Description:
Diabetes frequently leads to decreased sensation in the legs caused by diabetic peripheral neuropathy (DPN). DPN is an important risk factor for the development of foot ulceration, one of the most common causes for hospital admissions and lower-limb amputations among diabetic patients. However, to date there are no medications currently approved by the Food and Drug Administration to treat DPN.
The goal of this research project is to assess the effectiveness of a non-invasive, patented peristaltic pulse pneumatic compression device (the NormaTec PCD) in a home treatment program to improve the symptoms of DPN (e.g. numbness, pain, and tingling in the legs) and the underlying functioning of the nerves in the legs (as determined by sensory perception assessments and Nerve Conduction Studies testing).
In this prospective, randomized, double-blind study, subjects will be randomly placed in one of two groups: a control group using a sham NormaTec PCD ("placebo"); and an experimental group using a NormaTec PCD.
The goal of this research project is to assess the effectiveness of a non-invasive, patented peristaltic pulse pneumatic compression device (the NormaTec PCD) in a home treatment program to improve the symptoms of DPN (e.g. numbness, pain, and tingling in the legs) and the underlying functioning of the nerves in the legs (as determined by sensory perception assessments and Nerve Conduction Studies testing).
In this prospective, randomized, double-blind study, subjects will be randomly placed in one of two groups: a control group using a sham NormaTec PCD ("placebo"); and an experimental group using a NormaTec PCD.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R43DK088634-01 | NIH | None | https://reporter.nih.gov/quic… | View |