Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05414968
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2022-06-07
Brief Title:
A Novel Non-Pharmacological Treatment of Diabetic Neuropathy
Sponsor:
Auburn University
Organization:
Auburn University
Study Overview
Official Title:
A Novel Non-Pharmacological Treatment of Diabetic Neuropathy
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
To address a gap in DPN treatments we propose a pragmatic approach towards the development of mechanistically justified therapies to treat DPN Specifically we seek to explore undertested non-pharmacological approaches to DPN management through a pilot study establishing safety and feasibility as quantified by biomechanical and sensory-perception changes
The innovation central to this approach is in the multifactorial combination of pressure heat and vibration stimuli to improve foot sensation by 1 reducing edema in the foot and leg via improved venous return and lymphatic return 2 improving arterial flow both in large small and micro-vascular vessels 3 stimulating endothelial mechanisms like the increase of nitrous oxide that increases microvascular health through alternating compressive pressures from the foot to the thigh and 4 stimulating nerves through vibration to facilitate nerve repair This approach has the potential to address an unmet need in DPN namely interventions that can address underlying causes of neuropathy To this end the proposed research has two specific aims 1 the construction of a device capable of applying pressure heat and vibration to the entire lower extremity for treatment of neuropathy and 2 validation of safety and feasibility of the non-pharmacological intervention device
At the beginning of the study foot sensation and blood flow baseline measures will be taken with the foot sensation diagnostic tool and phase-contrast MRI with a footankle coil Siemens FootAnkle 16 at the Auburn University MRI Research Center respectively The foot sensation diagnostic tool has undergone testing with over 100 participants with diabetes and has shown the ability to establish the threshold sensitivity of the sole of the foot from 05 to 10 grams force an order of magnitude more accurate than the standard clinical monofilament-based measure used to establish foot sensitivity and diagnose DPN The phase-contrast MRI is a highly accurate measure of blood flow which we will use to validate the mechanistic hypothesis of the proposed non-pharmacological intervention The phase-contrast MRI does not require the use of contrast-enhancing dyes and will therefore exclude fewer diabetic participants than contrast-enhanced MRI scans
During the study each participant will receive the same 45-minute intervention on 10 days spread over no more than 14 days total in a similar manner to IPC studies At the end of each session pain will be assessed on scales such as the Defense and Veterans Pain Rating Scale DVPRS to establish the safety of the proposed intervention Feasibility will be determined of time to set up put on and take off the device Pre-study baseline measurements of foot sensation via the assessment tool will be compared to post-study measurements to establish any beneficial effect and provide variance for a power analysis to guide the design of future studies We hypothesize that non-neuropathic diabetic participants may have subclinical neuropathic symptoms which cannot be measured by standard clinical tools but can be measured by the diagnostic device which may identify the potential for the device to have preventative as well as treatment applications
Sample Size Justification A sample size of 16 subjects 8 with non-neuropathic diabetic and 8 with neuropathic diabetic participants achieves 80 power to detect an effect size as measured in the change in pain scores of 055 using a paired t-test with a one tailed Type I error rate of 010 Examination of each subgroup will also be conducted A sample size of 8 subjects achieves 80 power to detect an effect size as measured in the change in pain scores of 08 using a paired t-test with a one tailed Type I error rate of 010 Therefore this small study will have statistical power to observe medium to large changes in pain rating or foot sensation or blood flow However it must be noted that achieving statistical significance is not the primary objective of a pilot study The primary objective is to demonstrate feasibility of the trial by initiating a small version of the trail identifying areas requiring refinement and collecting preliminary data provides preliminary evidence of intended effect
The innovation central to this approach is in the multifactorial combination of pressure heat and vibration stimuli to improve foot sensation by 1 reducing edema in the foot and leg via improved venous return and lymphatic return 2 improving arterial flow both in large small and micro-vascular vessels 3 stimulating endothelial mechanisms like the increase of nitrous oxide that increases microvascular health through alternating compressive pressures from the foot to the thigh and 4 stimulating nerves through vibration to facilitate nerve repair This approach has the potential to address an unmet need in DPN namely interventions that can address underlying causes of neuropathy To this end the proposed research has two specific aims 1 the construction of a device capable of applying pressure heat and vibration to the entire lower extremity for treatment of neuropathy and 2 validation of safety and feasibility of the non-pharmacological intervention device
At the beginning of the study foot sensation and blood flow baseline measures will be taken with the foot sensation diagnostic tool and phase-contrast MRI with a footankle coil Siemens FootAnkle 16 at the Auburn University MRI Research Center respectively The foot sensation diagnostic tool has undergone testing with over 100 participants with diabetes and has shown the ability to establish the threshold sensitivity of the sole of the foot from 05 to 10 grams force an order of magnitude more accurate than the standard clinical monofilament-based measure used to establish foot sensitivity and diagnose DPN The phase-contrast MRI is a highly accurate measure of blood flow which we will use to validate the mechanistic hypothesis of the proposed non-pharmacological intervention The phase-contrast MRI does not require the use of contrast-enhancing dyes and will therefore exclude fewer diabetic participants than contrast-enhanced MRI scans
During the study each participant will receive the same 45-minute intervention on 10 days spread over no more than 14 days total in a similar manner to IPC studies At the end of each session pain will be assessed on scales such as the Defense and Veterans Pain Rating Scale DVPRS to establish the safety of the proposed intervention Feasibility will be determined of time to set up put on and take off the device Pre-study baseline measurements of foot sensation via the assessment tool will be compared to post-study measurements to establish any beneficial effect and provide variance for a power analysis to guide the design of future studies We hypothesize that non-neuropathic diabetic participants may have subclinical neuropathic symptoms which cannot be measured by standard clinical tools but can be measured by the diagnostic device which may identify the potential for the device to have preventative as well as treatment applications
Sample Size Justification A sample size of 16 subjects 8 with non-neuropathic diabetic and 8 with neuropathic diabetic participants achieves 80 power to detect an effect size as measured in the change in pain scores of 055 using a paired t-test with a one tailed Type I error rate of 010 Examination of each subgroup will also be conducted A sample size of 8 subjects achieves 80 power to detect an effect size as measured in the change in pain scores of 08 using a paired t-test with a one tailed Type I error rate of 010 Therefore this small study will have statistical power to observe medium to large changes in pain rating or foot sensation or blood flow However it must be noted that achieving statistical significance is not the primary objective of a pilot study The primary objective is to demonstrate feasibility of the trial by initiating a small version of the trail identifying areas requiring refinement and collecting preliminary data provides preliminary evidence of intended effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None