Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
Diabetic Ulcer of Plantar Aspect of Left FootDiabetic Ulcer of Plantar Aspect of Right Foot1 moreAnecdotal reports and scientific literature suggest that the risk of recurrence of diabetic foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve pinching and entrapment. Historical risk of 25% annually has been reported to decrease by >80% to under 5% yearly. Since an open wound precedes the large majority (85%) of amputations in diabetes, avoidance of ulcer recurrences is important. This study tests the current academic opinion that nerve decompression will not decrease ulcer recurrence risk. Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
Effects of Early Stepping Verticalization + FES on CIP
Critical Illness PolyneuropathyAcquired Brain InjuryBackground: Intensive Care Unit (ICU) survivors often develop an acquired weakness due to a Critical Illness Polyneuropathy (CIP). Early mobilization in ICU, by reducing the bed rest and decreasing the oxidative stress, was shown to represent a valid preventive option. Purpose: To evaluate whether ICU sessions of stepping verticalization associated with Functional Electrical Stimulation (FES) of the lower limbs are able to reduce the occurrence of CIP in Acquired Brain Injured (ABI) patients. Methods: all the ABI patients admitted in our Neurorehabilitation Unit from our ICU were retrospectively evaluated. Patients affected by previous peripheral neuropathy, diabetes, cancer, alcoholism, viral hepatitis, AIDS and autoimmune diseases were excluded. They were divided into 3 groups according to the rehabilitation strategy received in ICU: group 1 received conventional physiotherapy + stepping verticalization sessions with Erigo® (Hocoma, Switzerland); group 2 received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro®; group 3 received only conventional physiotherapy. As for internal protocol, all patients started rehabilitation in the first week from the ABI and performed 60 minutes/day of rehabilitation, 5 days/week. Primary outcome was the evidence of CIP at Neurorehabilitation admission (=ICU discharge), according to neurophysiological criteria. Secondary outcomes were the strength impairment at Neurorehabilitation discharge, measured by the total Motricity Index score and the Functional Ambulation Classification (FAC) score, assessing quality of gait.
An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)...
Chronic Inflammatory Demyelinating PolyneuropathyThis is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient Chronic Inflammatory Demyelinating Polyneuropathy, CIDP. The expanded access program will include a screening period of up to 28 days, a 44-week treatment period, a safety follow-up at 50, and a 52-week end-of-study visit.
Innovative Ultrasound Technology in Neuromuscular Disease
Amyotrophic Lateral SclerosisMuscular Dystrophy5 moreThis study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.
Electrodiagnostic Parameters in Patients With Impaired Glucose Tolerance and Diabetes Mellitus
Impaired Glucose TolerancePeripheral Polyneuropathy1 moreThe purpose of this study is to evaluate the distal sensory nerves of the feet, namely, the dorsal sural, medial dorsal cutaneous and medial plantar nerves, in patients with impaired glucose tolerance and diabetes mellitus type 2 and compare these parameters to those from healthy participants.
Use of GDF15 as a Biomarker for Early Diagnosis of DM and Monitoring of Progress of Complications...
Diabetes MellitusType 22 moreSignificant differences in the expression of individual Growth Differentiation Factor 15 (GDF-15) proteins among Taiwanese harboring different mitochondrial genotypes are noted, and their blood serum levels also exhibited associations with diabetes. GDF-15 was originally discovered as an autocrine regulator of macrophage activation and shown to play important roles in fibrosis, malignancy, cardiovascular disease, glycemic control, and obesity. However, the relationship between GDF-15 and pre-diabetes and diabetes in Asian populations has yet to be fully investigated. Besides, any indirect associations between GDF-15 levels and diabetic complications remain unclear. The investigators aim to further investigate the role of GDF-15 levels in the initial diagnosis of diabetes, the monitoring of medication effectiveness and disease progression, and related complications such as diabetic nephropathy and neuropathy. The DNA isolated from the blood samples will be evaluated to determine individual mitochondria haplogroups, including variants located within the coding and control regions of the mitochondrial genome.
Quantification of Nerve Stiffness in Neuropathies
Chronic Inflammatory Demyelinating PolyneuropathyCharcot-Marie-Tooth Disease2 moreThis project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer
Cognition DisordersPolyneuropathiesNeurotoxic phenomena are among the most common and difficult to treat side effects of chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a well-recognized adverse reaction in the peripheral nervous system. Side effects of chemotherapy in the central nervous system, however, particularly changes of cognitive function (in non-medical literature referred to as "chemobrain") are diffuse and difficult to attribute to individual cytostatic drugs. The primary purpose of this study is to assess cognitive function in patients with ovarian and breast cancer before and after systemic chemotherapy with paclitaxel with standardized neuropsychological tests and compare the outcome to patients with benign gynecological tumors and breast cancer without chemotherapy treatment, respectively. Secondary parameters include the assessment of olfactory function, total neuropathy score and cytokine profiles.
Biomarker for Transthyretin-Related Familial Amyloidotic Polyneuropathy (BioTRAP)
Transthyretin AmyloidosisTransthyretin-Related (ATTR) Familial Amyloid Polyneuropathy1 moreInternational, multicenter, observational, longitudinal study to identify biomarker/s for the development of a new MS-based biomarker for the early and sensitive diagnosis of Transthyretin-Related Familial Amyloidotic Polyneuropathy from blood and number of correctly identified patients with Transthyretin-Related Familial Amyloidotic Polyneuropathy
Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR)
TTR-mediated AmyloidosisAmyloidosis8 moreThe purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).