Diabetic Neuropathies Clinical Trial
Official title:
Effects of the Use of Customized Silicone Digital Orthoses on Pre-ulcerative Lesions and Plantar Pressure During Walking in People With Diabetic Neuropathy: a Randomized Controlled Clinical Trial
The present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the International Working Group on Diabetic Foot.
The present study aims to evaluate the effects and safety of the use of customized silicone digital orthoses for six months in the plantar pressure distribution during gait, in the reduction of pre-ulcerative lesions and plantar ulcers at forefoot, in functional balance, foot deformities, quality of life and foot health and functionality in people with diabetes and and diabetic neuropathy with risk category 2 and 3, according to the International Working Group on Diabetic Foot. The sample will consist of 60 participants, who will be randomly allocated, in a randomized controlled clinical trial, in the control or intervention groups and evaluated at baseline, 3 and 6 months of follow up. The assessment includes (1) classification of the risk of foot ulceration, (2) analysis of plantar pressure during gait, (3) quality of life, (4) foot deformities, (5) pre-ulcerative lesions, (6) functionality and general health of the feet. The hypothesis of this study is that the intervention group will present a reduction in the peak pressures during gait, a reduction in hyperkeratosis at forefoot, a reduction in the incidence and recurrence of forefoot ulcerations, and improved quality of life and in the functionality and health of the foot, when compared to the control group after six months of use of silicone digital orthoses. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04106050 -
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
|
Phase 1 | |
| Completed |
NCT04088929 -
The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy
|
Phase 2 | |
| Completed |
NCT01939366 -
Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
|
Phase 2 | |
| Withdrawn |
NCT00815932 -
The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy
|
N/A | |
| Completed |
NCT01926522 -
Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients
|
N/A | |
| Not yet recruiting |
NCT01180608 -
Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain
|
N/A | |
| Completed |
NCT00760955 -
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
|
Phase 2 | |
| Completed |
NCT00380913 -
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
|
Phase 4 | |
| Terminated |
NCT00756041 -
Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy
|
Phase 2 | |
| Completed |
NCT05255497 -
The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
|
N/A | |
| Completed |
NCT06061237 -
Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy
|
N/A | |
| Terminated |
NCT02915263 -
The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
|
Phase 2 | |
| Enrolling by invitation |
NCT05043636 -
Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
|
||
| Completed |
NCT06373809 -
Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy
|
Early Phase 1 | |
| Completed |
NCT05968131 -
Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy
|
N/A | |
| Completed |
NCT00282685 -
Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy
|
Phase 1 | |
| Completed |
NCT00135109 -
Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
|
Phase 3 | |
| Completed |
NCT06292962 -
Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain
|
N/A | |
| Completed |
NCT05058807 -
Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy .
|
N/A | |
| Not yet recruiting |
NCT04092140 -
Neuromuscular Ultrasound in Correlation to Neurophysiological Findings
|