Diabetic Peripheral Neuropathy Clinical Trial
Official title:
A Novel Non-Pharmacological Treatment of Diabetic Neuropathy
NCT number | NCT05414968 |
Other study ID # | 22-114 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 22, 2023 |
Est. completion date | June 1, 2025 |
The objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), to improve quality of life of individuals with diabetes, and reduce the prevalence of opiate prescription, sensation loss, falls, and deaths caused by DPN. To this end, the proposed study will investigate and determine the feasibility of the non-pharmacological intervention device. The feasibility study involves 16 participants, split evenly between pre-neuropathic diabetic and neuropathic diabetic participants. During the study, each group will receive the same 45-minute intervention on 10 days spread over no more than 14 days total. Feasibility will be determined by change in pain assessed before and after intervention.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | June 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosis of type 2 diabetes for at least 5 years - lab histories that verify participant's control or lack of blood sugars dating back for a period of 1-5 years Exclusion Criteria: - other diseases or impairments that could affect results (vascular disease verified from medical history - ankle-brachial index (ABI) of 0.9 or less |
Country | Name | City | State |
---|---|---|---|
United States | Auburn University | Auburn | Alabama |
Lead Sponsor | Collaborator |
---|---|
Auburn University |
United States,
Buckenmaier CC 3rd, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013 Jan;14(1):110-23. doi: 10.1111/j.1526-4637.2012.01516.x. Epub 2012 Nov 8. — View Citation
Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005. — View Citation
Lotz J, Meier C, Leppert A, Galanski M. Cardiovascular flow measurement with phase-contrast MR imaging: basic facts and implementation. Radiographics. 2002 May-Jun;22(3):651-71. doi: 10.1148/radiographics.22.3.g02ma11651. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Pain Assessment | Defense and Veterans Pain Rating Scale (DVPRS) | immediately after each session (up to 30 minutes) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04638556 -
Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
|
||
Completed |
NCT05580705 -
Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
|
N/A | |
Completed |
NCT02127762 -
The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy
|
N/A | |
Terminated |
NCT01620775 -
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
|
N/A | |
Completed |
NCT00835757 -
Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
|
N/A | |
Recruiting |
NCT00553592 -
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
|
Phase 2 | |
Recruiting |
NCT05863793 -
Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
|
N/A | |
Withdrawn |
NCT05041816 -
Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy
|
N/A | |
Recruiting |
NCT06074562 -
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
|
Phase 2 | |
Recruiting |
NCT04457531 -
LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
|
Early Phase 1 | |
Completed |
NCT02947828 -
Polyneuropathy in Diabetes Mellitus Type 2
|
||
Completed |
NCT02056431 -
Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
|
N/A | |
Completed |
NCT01681290 -
Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT01474772 -
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
|
Phase 3 | |
Completed |
NCT01086150 -
Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy
|
Phase 2/Phase 3 | |
Completed |
NCT03447756 -
Titration Study of ABX-1431
|
Phase 1 | |
Completed |
NCT04688671 -
Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
|
Phase 2 | |
Completed |
NCT04984044 -
Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms
|
N/A | |
Completed |
NCT06130917 -
Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN.
|
N/A | |
Completed |
NCT01496365 -
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
|
Phase 2 |