Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646731
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Cryoneurolysis for Painful Diabetic Neuropathy of the Foot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultrasound-guided Percutaneous Cryoneurolysis for Management of Chronic Painful Diabetic Neuropathy a Randomized Sham-controlled Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a single-center randomized participant- and observer-masked human-subjects post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot A prolonged nerve block may be provided by freezing the nerve using a technique called cryoneurolysis With cryoneurolysis and ultrasound machines a small needle-like probe may be placed through anesthetized skin and guided to the target nerve to allow freezing The procedure takes about 6 minutes for each nerve involves little discomfort has no systemic side effects and cannot be misused or become addictive Participants will be randomly allocated to one of two possible treatments groups cryoneurolysis experimental or sham control The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure
Detailed Description:
The study is a single-center randomized participant- and observer-masked human-subjects post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot A prolonged nerve block may be provided by freezing the nerve using a technique called cryoneurolysis With cryoneurolysis and ultrasound machines a small needle-like probe may be placed through anesthetized skin and guided to the target nerve to allow freezing The procedure takes about 6 minutes for each nerve involves little discomfort has no systemic side effects and cannot be misused or become addictive After 2-3 months the nerve returns to normal functioning Participants will be randomly allocated to one of two possible treatments groups cryoneurolysis experimental or sham control The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure
Our objective is to investigate the therapeutic benefits of cryoneurolysis for research participants with painful diabetic neuropathy of the feet via a pilot study of 30 research participants We hypothesize that ultrasound-guided cryoneurolysis of the superficial peroneal nerve will improve pain outcomes in research participants with painful diabetic neuropathy of the foot The aims of this study will be to
Primary Specific Aim Demonstrate the potential efficacy of ultrasound-guided percutaneous cryoneurolysis of the superficial peroneal nerve sural distal saphenous andor deep peroneal nerve to treat painful diabetic neuropathy of the foot in reducing neuropathic pain 1 month after the procedure compared to baseline This will be performed as a pilot study and executed as a randomized sham-controlled clinical trial of 30 subjects
Hypothesis 1 Diabetic neuropathic pain intensity will be decreased relative to baseline 1 month following a cryoneurolysis procedure as measured by the Neuropathic Pain Scale
Secondary Specific Aim To test the influence of a cryoanalgesia treatment as compared to shamplacebo on the long term measurements related to pain quality of life and analgesic usage
Hypothesis 2a Perception of well-being will be improved 1 month following one cryoneurolysis procedure as measured with the Patient Global Impression of Change Scale
Hypothesis 2b Physical and emotional functioning will be improved relative to baseline 1 month following one cryoneurolysis procedure as measured with the Interference Subscale of the Brief Pain Inventory
Hypothesis 2c Pain and opioid consumption will be reduced in the cryoneurolysis group compare to sham at multiple post-procedure time points including 1 week 1 month 3 months and 6 months after
Our objective is to investigate the therapeutic benefits of cryoneurolysis for research participants with painful diabetic neuropathy of the feet via a pilot study of 30 research participants We hypothesize that ultrasound-guided cryoneurolysis of the superficial peroneal nerve will improve pain outcomes in research participants with painful diabetic neuropathy of the foot The aims of this study will be to
Primary Specific Aim Demonstrate the potential efficacy of ultrasound-guided percutaneous cryoneurolysis of the superficial peroneal nerve sural distal saphenous andor deep peroneal nerve to treat painful diabetic neuropathy of the foot in reducing neuropathic pain 1 month after the procedure compared to baseline This will be performed as a pilot study and executed as a randomized sham-controlled clinical trial of 30 subjects
Hypothesis 1 Diabetic neuropathic pain intensity will be decreased relative to baseline 1 month following a cryoneurolysis procedure as measured by the Neuropathic Pain Scale
Secondary Specific Aim To test the influence of a cryoanalgesia treatment as compared to shamplacebo on the long term measurements related to pain quality of life and analgesic usage
Hypothesis 2a Perception of well-being will be improved 1 month following one cryoneurolysis procedure as measured with the Patient Global Impression of Change Scale
Hypothesis 2b Physical and emotional functioning will be improved relative to baseline 1 month following one cryoneurolysis procedure as measured with the Interference Subscale of the Brief Pain Inventory
Hypothesis 2c Pain and opioid consumption will be reduced in the cryoneurolysis group compare to sham at multiple post-procedure time points including 1 week 1 month 3 months and 6 months after
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None