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Axon Therapy + CMM for Diabetic Neuropathy
Study Summary
This trial compares two treatments for reducing neuropathic pain in people with PDM: Axon Therapy plus usual care, vs. sham treatment plus usual care.
- Diabetic Neuropathy
- Neuropathic Pain
- Neuralgia
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have been experiencing pain from diabetic neuropathy in your lower limbs for at least three months according to your medical records.You have skin conditions in the same area as your nerve pain that might make it difficult to accurately evaluate your pain.You have any other condition that may cause similar symptoms to peripheral diabetic neuropathy (PDN), like tarsal tunnel syndrome, sciatica, bunions, ischemic claudication, or foot or ankle arthritis.You have a progressive neurological disease like multiple sclerosis or a severe spinal condition.You have other types of pain that could make it difficult to assess or evaluate your specific nerve-related pain.The researcher thinks you might be at risk of hurting yourself or thinking about suicide.You have already tried another implantable device for the same health problem, but it didn't work.You have significant pain rated as 5 or higher on a pain scale.You are willing and able to comply with the study protocol.You are a male or female of any race or ethnicity who is 18-75 years of age.You have nerve pain caused by conditions like shingles, HIV, or trigeminal neuralgia. Your nerve pain is not from a spinal cord injury.You have ongoing or recurring pain that is more than just mild, and it may make it hard for you to accurately describe your pain during the study.You have other serious medical or mental health conditions, or abnormal lab results, or any other factors that could make participating in the study risky or affect the results.You experience pain in a body part that is missing or no longer there.You have metal objects or fragments in your body.You have been actively using drugs or alcohol in the past year.You must be literate in English to fill out the study questionnaires.
- Group 1: Axon Therapy + CMM
- Group 2: Sham + CMM
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what demographic is this clinical trial open?
"This clinical trial seeks 80 individuals aged 18 and 75 with neuralgia. To qualify, they must fulfil the following criteria: having diabetic neuropathy type 2 in lower limbs for at least three months according to medical history; being able to sign an informed consent document pertaining to all relevant aspects of this study; willing and capable of adhering to standardised visits, treatment sessions, daily pain evaluation procedures etc.; literate in English (required for completing questionnaires); any race or ethnicity between those ages; Body Mass Index not exceeding 40; experiencing a certain degree of pain as indicated by VAS score at screening visit; submitting two daily entries"
Is a maximum age limit imposed on the participants of this trial?
"This particular clinical trial requires participants to be 18-75 years of age. There are 83 trials that cater specifically to those under the legal age, while 532 studies focus on people over 65."
How many volunteers are aiding in the research of this study?
"Affirmative. Clinicaltrials.gov data suggests that this research is presently seeking volunteers, which was first posted on December 1st 2022 and revised five days ago. To complete the study, 80 individuals must be enrolled at 5 distinct medical centres."
Does this experiment currently have room for more participants?
"Affirmative, the clinicaltrials.gov website indicates that this medical trial is currently looking for participants. The investigation was first announced on December 1st 2022 and has since been updated on December 5th of the same year. This study necessitates 80 patients from five different centres."
What is the goal of this research endeavor?
"NeuraLace Medical, Inc., the trial sponsor, has specified that their primary outcome to be measured over a 30 day period is any adverse events related to therapy between both study arms. Additionally, this research will evaluate secondary outcomes including changes in self-reported pain levels from baseline readings overall and by group as well as daily diary entries for numbness and adjustments in Depression Anxiety Stress Scale scores relative to initial measurements."
In which locations is this clinical experiment being conducted?
"This research initiative is currently taking place in 5 distinct locations, including Saint Petersburg, Vero Beach and Waycross. To reduce participant travel times, it may be prudent to choose the nearest site as your point of enrollment."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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