Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study (NCT05993871) | Clinical Trial Compass
CompletedNot Applicable
Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study
Egypt45 participantsStarted 2023-01-01
Plain-language summary
The aim of work is to study the clinical, electrodiagnostic and neurosonographic characteristics of diabetic patients with small fiber neuropathy in the Egyptian population, and to evaluate both the diagnostic and the prognostic impact of the studied factors on the neuropathy severity and quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients diagnosed with diabetes mellitus or impaired glucose intolerance by laboratory investigations including any of the following: HbA1C, fasting blood sugar and 2-hour post prandial blood sugar, and/or antidiabetic medication.
. Patients presented with small fiber neuropathy (SFN), including all the following:
. Age older than 18 years old
Exclusion criteria
. Mental illness that made interviewing ineffective
. Physical illness leading to language and/or cognitive barrier
. Other conditions that could cause neuropathy (e.g., chemotherapy, alcohol intake, established vitamin B12 deficiency, established hereditary neuropathy "or first-degree family members", active malignancy, chronic advanced liver or kidney diseases thought to cause neuropathy and history of bariatric surgery).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstrate the findings of UENS in the studied groups
Timeframe: through study completion, an average of 9 months
2
Demonstrate the findings of TCNS in the studied groups
Timeframe: through study completion, an average of 9 months
3
Demonstrate the findings of EuroQOL-5D-5L in the studied groups
Timeframe: through study completion, an average of 9 months
4
Demonstrate the findings of nerve conduction studies protocol of the performed nerves in the studied groups.
Timeframe: through study completion, an average of 9 months
5
Demonstrate the findings of cutaneous silent period in the studied groups.
Timeframe: through study completion, an average of 9 months
6
Demonstrate the findings of sympathetic skin response in the studied groups.
Timeframe: through study completion, an average of 9 months
7
Demonstrate the findings of Ewing battery in the studied groups.