Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480786
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-24
Brief Title:
SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy and Peripheral Arterial Disease Mechanistic Insights From a Single-center Randomized Blinded Sham-controlled Cross-over Proof-of-concept Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 study involves permanent spinal cord stimulator SCS placement in participants with peripheral arterial disease PAD and painful diabetic neuropathy PDN Participants will be between 19 and 89 years old have diabetes with symptoms of neuropathy and have a starting pain level of at least 5 cm on a visual pain scale They must also have PAD confirmed by an ankle-brachial index under 090 or vascular imaging and experience pain from walking with a pain level of at least 6 cm for at least 3 months Their Vascular Quality of Life Questionnaire score should be 55 or less and they must be good candidates for SCS
The study includes initial evaluation visits follow up after their permanent SCS is placed and optimized 12 weeks in the clinic at this time the study interventions begin and the patient is followed for four weeks two weeks of stimulation and two weeks of sham intervention in random order and intervention evaluations At each follow up visit pain sensory functional vascular and autonomic outcomes will be assessed after which patients will return to standard SCS care The total time for the study intervention is 4 weeks
The study includes initial evaluation visits follow up after their permanent SCS is placed and optimized 12 weeks in the clinic at this time the study interventions begin and the patient is followed for four weeks two weeks of stimulation and two weeks of sham intervention in random order and intervention evaluations At each follow up visit pain sensory functional vascular and autonomic outcomes will be assessed after which patients will return to standard SCS care The total time for the study intervention is 4 weeks
Detailed Description:
The study will include ten total participants with peripheral arterial disease PAD and painful diabetic neuropathy PDN who meet inclusion criteria for permanent spinal cord stimulator SCS placement Participants will be between 19 and 90 years old have diabetes with symptoms of neuropathy and have a starting pain level of at least 5 cm on a visual pain scale They must also have PAD confirmed by an ankle-brachial index under 090 or vascular imaging and experience pain from walking with a pain level of at least 6 cm for at least 3 months Their Vascular Quality of Life Questionnaire score should be 55 or less and they must be good candidates for SCS
The interventions will include spinal cord stimulation versus sham stimulation using a cross over design Evaluations will include 1 week follow up clinical visit 2 week follow up clinical visit with vascular lab TcPO2 evaluation 12-week post permanent SCS placement with randomization to receive either active spinal cord stimulation or sham stimulation at a 2 week interval follow up visit 2 weeks later to change therapy and finally 2 weeks later to resume regular spinal cord stimulation At each follow up visit pain sensory functional vascular and autonomic outcomes will be assessed The study intervention lasts for 4 weeks after which patients will return to standard SCS care
The interventions will include spinal cord stimulation versus sham stimulation using a cross over design Evaluations will include 1 week follow up clinical visit 2 week follow up clinical visit with vascular lab TcPO2 evaluation 12-week post permanent SCS placement with randomization to receive either active spinal cord stimulation or sham stimulation at a 2 week interval follow up visit 2 weeks later to change therapy and finally 2 weeks later to resume regular spinal cord stimulation At each follow up visit pain sensory functional vascular and autonomic outcomes will be assessed The study intervention lasts for 4 weeks after which patients will return to standard SCS care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None