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Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy

2014-08-27 03:53:19 | BioPortfolio

Summary

The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy.

Description

Primary objective:

To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection. To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.

Secondary objective:

To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Diabetic Neuropathy

Intervention

hVEGF-A

Location

San Antonio
Texas
United States
78229-4801

Status

Completed

Source

Sangamo Biosciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:19-0400

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Medical and Biotech [MESH] Definitions

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Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

Disorder of the peripheral nerves that primarily impair small nerve fibers. The affected small nerve fibers include myelinated A-delta fibers (see A FIBERS) and unmyelinated C FIBERS. Because these small fibers innervate skin and help control autonomic function, their neuropathy presents with neuropathic pain, reduced thermal and pain sensitivity, and autonomic dysfunction (e.g. abnormal sweating or facial flushing). Small fiber neuropathy can be idiopathic or associated with underlying diseases (e.g., AMYLOIDOSIS; DIABETES MELLITUS; SARCOIDOSIS; or VASCULITIS).

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