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Diabetic Neuropathies clinical trials

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NCT ID: NCT01296308 Completed - Clinical trials for Diabetes Mellitus, Type 2

Complementary and Integrative Therapy for Diabetic Neuropathy

CIT-DN
Start date: March 2011
Phase: N/A
Study type: Observational

Despite the long tradition of complementary and alternative medicine (CAM) therapies there are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes aspects of conventional and traditional European and Chinese medicine, mind-body medicine, physical therapy and lifestyle modification (nutrition advices, stress management and exercise training). The observational design intends four measurement points: tree months before (T0), directly before (T1), directly after treatment (T2) and three months follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity, locus of control, interpretation of illness, coping style, anxiety/depression, life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a qualitative interview should give a view to patient perspective of therapy process.

NCT ID: NCT01293461 Completed - Diabetes Mellitus Clinical Trials

Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.

NCT ID: NCT01263132 Completed - Clinical trials for Diabetic Neuropathies

Neuropathic Pain Management

M-F0434
Start date: February 2008
Phase: Phase 3
Study type: Interventional

This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.

NCT ID: NCT01261442 Completed - Clinical trials for Distal Symmetric Polyneuropathy (DSPN)

Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Start date: January 2011
Phase: N/A
Study type: Observational

The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN. This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.

NCT ID: NCT01261143 Completed - Clinical trials for Diabetic Neuropathies

Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy

Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the: Primary end point - change of Total symptom score Secondary end point - neurological test

NCT ID: NCT01251211 Completed - Clinical trials for Postherpetic Neuralgia

Botulinum Toxin in Peripheral Neuropathic Pain

Start date: October 2010
Phase: Phase 4
Study type: Interventional

Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.

NCT ID: NCT01247558 Completed - Clinical trials for Diabetic Peripheral Neuropathy (DPN)

Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Start date: November 2010
Phase: N/A
Study type: Observational

This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

NCT ID: NCT01235260 Completed - Diabetes Mellitus Clinical Trials

Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes

Start date: March 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.

NCT ID: NCT01207284 Completed - Clinical trials for Foot and Ankle Muscle Weakness

Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy

Start date: August 2010
Phase: Phase 1
Study type: Interventional

The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. The participants will be randomly assigned into control group (regular treatment prescribed by their medical group) or into treatment group, that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes each session. This will aim for increasing foot and ankle range of movement, muscle strength and improving sensory inputs.

NCT ID: NCT01179672 Completed - Clinical trials for Diabetic Neuropathy, Painful

A Study in Participants With Diabetic Peripheral Neuropathic Pain in China

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.