Gene Therapy for Painful Diabetic Neuropathy
Summary
The purpose of this study is to assess the safety and tolerability of injecting VM202 in the leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with DPN.
Description
Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction.
Currently, there are no approved drugs or interventional strategies known to halt or reverse the progression of DPN. Treatments target pain reduction, physical function improvement, reduction of psychological distress, and quality of life improvements.
There is currently no effective treatment for diabetic neuropathy, and good glycemic control is the only way to minimize the risk of occurrence. Clearly, it would be desirable to prevent, impede, or reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons.
Study Design
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Painful Diabetic Neuropathy
Intervention
VM202
Location
Diablo Clinical Research Hospital
Walnut Creek
California
United States
94598
Status
Not yet recruiting
Source
ViroMed Co., Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01002235
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:12:17-0400
Clinical Trials
Graded Exposure in Patients With Painful Diabetic Neuropathy
Objective: To investigate the effects of a cognitive behavioural intervention targeting specific fears in patients with painful diabetic neuropathy, on physical activity and quality of lif...
Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy
The purpose of this study is to determine if vaporized cannabis is effective as an analgesic for the treatment of painful diabetic neuropathy.
Trazodone in Painful Diabetic Neuropathy
The aim of the study is to collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the neurop...
A Study for the Treatment of Painful Diabetic Neuropathy
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
PubMed Articles
Reduced vitamin D levels in painful diabetic peripheral neuropathy.
Recent studies have reported an association between low vitamin D levels and diabetic peripheral neuropathy. However, many of these did not differentiate between people with painful diabetic periphera...
To determine the role of mechanical allodynia (MA) in predicting good surgical outcome for painful diabetic peripheral neuropathy (DPN).
Painful diabetic neuropathy (PDN) is one of the most frequent complications of diabetes and the current therapies have limited efficacy. This study aimed to study the neuroprotective effect of duloxet...
To assess the efficacy of surgical decompression of lower extremity nerves for the treatment of painful diabetic peripheral sensorimotor polyneuropathy (DPN).
Medical and Biotech [MESH] Definitions
Diabetic Neuropathies
Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)
Optic Neuropathy, Ischemic
Ischemic injury to the OPTIC NERVE which usually affects the OPTIC DISK (optic neuropathy, anterior ischemic) and less frequently the retrobulbar portion of the nerve (optic neuropathy, posterior ischemic). The injury results from occlusion of arterial blood supply which may result from TEMPORAL ARTERITIS; ATHEROSCLEROSIS; COLLAGEN DISEASES; EMBOLISM; DIABETES MELLITUS; and other conditions. The disease primarily occurs in the sixth decade or later and presents with the sudden onset of painless and usually severe monocular visual loss. Anterior ischemic optic neuropathy also features optic disk edema with microhemorrhages. The optic disk appears normal in posterior ischemic optic neuropathy. (Glaser, Neuro-Ophthalmology, 2nd ed, p135)
Familial Multiple Lipomatosis
A rare autosomal disorder characterized by numerous encapsulated lipomas on the trunk and extremities. The lipomas are usually not painful but can cause pain when growing. In rare cases, one lipoma can become painful and progress to multiple painful lipomas; it is then referred to as Dercum's Disease Type III
Femoral Neuropathy
Disease involving the femoral nerve. The femoral nerve may be injured by ISCHEMIA (e.g., in association with DIABETIC NEUROPATHIES), nerve compression, trauma, COLLAGEN DISEASES, and other disease processes. Clinical features include MUSCLE WEAKNESS or PARALYSIS of hip flexion and knee extension, ATROPHY of the QUADRICEPS MUSCLE, reduced or absent patellar reflex, and impaired sensation over the anterior and medial thigh.
Diabetic Foot
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.
