Small Fiber NeuropathyNCT05993871
Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study
An observational study of Small Fiber Neuropathy and Diabetic Neuropathies, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small Fiber Neuropathy, Diabetic Neuropathies, Autonomic Neuropathy
- What is being tested?
- Clinical Evaluation/Questionnaires, Nerve Conduction Study and Small fiber electrodiagnostic tests
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group I: Patients with diabetic small fiber neuropathy Group II: Patients with diabetic mixed small and large fiber neuropathy Group III: Subjects without neuropathy
Who may be able to join
- 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:
- Typical clinical symptoms of SFN such as burning or sharp pain in toes and feet, and on clinical examination: loss of small fiber modalities (pinprick and temperature), hyperalgesia, allodynia, and/or autonomic signs.
- Reduced intraepidermal nerve fiber density (IENFD) in distal leg skin punch biopsy.
- Age older than 18 years old
Who cannot join
- 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).
- Atrial Fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This case-control observational study is aiming to evaluate patients with diabetic small fiber neuropathy in the Egyptian.
Diabetic small fiber neuropathy was defined as both of the following:
- Typical clinical symptoms of SFN such as burning or sharp pain in toes and feet, and on clinical examination: loss of small fiber modalities (pinprick and temperature), hyperalgesia, allodynia, and/or autonomic signs.
- Reduced intraepidermal nerve fiber density (IENFD) in distal leg skin punch biopsy.
The study includes 3 groups:
Group I: Patients with diabetic small fiber neuropathy Group II (Control Group): Patients with diabetic mixed small and large fiber neuropathy Group III (Control Group): Subjects without peripheral neuropathy
Clinical evaluation includes: Neuropathic Pain 4 (DN4) questionnaire, 11-point Numeric Pain Scale (NPS), Utah Early Neuropathy Scale (UENS), Toronto Clinical Neuropathy Scale (TCNS), Composite Autonomic Symptom Score (COMPASS-31), an Arabic version, and several anthropometric measures; including: body weight in kilograms, height in centimeters, waist circumference measured in centimeters at the top of the iliac crest, and systolic "SBP" and diastolic "DBP" blood pressure measurement in mmHg.
Electrodiagnostic evaluation includes: routine nerve conduction study, cutaneous silent period by stimulating left median nerve and right sural nerve and recording from the abductor pollicis brevis and tibialis anterior muscles, respectively, bilateral hand-to hand and foot-to-foot sympathetic skin response, and Ewing battery using R-R interval analysis, in addition to the blood pressure tests.
Neurosonographic evaluation includes: bilateral vagal nerve scan at the mid-neck lateral to the thyroid cartilage, left median and right ulnar nerves scan at the mid-forearm, left tibial nerve at the distal ankle 2 to 4 fingerbreadths proximal to the medial malleolus, and right sural nerve 2 to 4 fingerbreadths proximal to the lateral malleolus. Nerves are evaluated for transverse cross-sectional area (CSA).
Severity and outcome measures are assessed using: NPS, TCNS, COMPASS-31, and the index score of Euro Quality of Life -5 Dimensions -5 Levels (EuroQOL-5D-5L), the Arabic version.
- Conditions
- Small Fiber Neuropathy, Diabetic Neuropathies, Autonomic Neuropathy, Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy, Diabetic Polyneuropathy
- Being tested
- Clinical Evaluation/Questionnaires, Nerve Conduction Study, Small fiber electrodiagnostic tests, Nerve Ultrasound, Skin Biopsy
- Medical subject headings
- Small Fiber Neuropathy, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Evaluation/QuestionnairesDiagnostic test
Anthropometric measures, somatosensory assessment (NPS, UENS, TCNS), autonomic assessment (COMPASS-31, Ewing battery), and severity and quality of life evaluation (NPS, TCNS, COMPASS-31, and EuroQOL-5D-5L index score)
Nerve Conduction StudyDiagnostic test
Routine Nerve Conduction Study.
Small fiber electrodiagnostic testsDiagnostic test
R-R interval analysis, Cutaneous Silent Period and Sympathetic Skin Response.
Nerve UltrasoundDiagnostic test
Bilateral vagal, left median, right ulnar, left tibial and right sural nerves ultrasound.
Skin BiopsyDiagnostic test
distal leg 3mm punch skin biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetic small fiber neuropathy | Diabetic Patients presented with pure small fiber neuropathy. Receives: Diagnostic Test: Clinical Evaluation/Questionnaires; Diagnostic Test: Nerve Conduction Study; Diagnostic Test: Small fiber electrodiagnostic tests; Diagnostic Test: Nerve Ultrasound; Diagnostic Test: Skin Biopsy | |
| Patients with diabetic mixed small and large fiber neuropathy | Diabetic Patients presented with mixed small and large fiber neuropathy Receives: Diagnostic Test: Clinical Evaluation/Questionnaires; Diagnostic Test: Nerve Conduction Study; Diagnostic Test: Small fiber electrodiagnostic tests; Diagnostic Test: Nerve Ultrasound; Diagnostic Test: Skin Biopsy | |
| Subjects without neuropathy | Healthy subjects without any symptoms and/or signs suggesting neuropathy, and within average IENFD on skin biopsy. Receives: Diagnostic Test: Clinical Evaluation/Questionnaires; Diagnostic Test: Nerve Conduction Study; Diagnostic Test: Small fiber electrodiagnostic tests; Diagnostic Test: Nerve Ultrasound; Diagnostic Test: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the findings of UENS in the studied groups
Demonstrate the findings of Utah early neuropathy scale in the studied groups to screen for neuropathic symptoms, where overall scores of 4 and more are considered positive.
Measured: through study completion, an average of 9 months
Demonstrate the findings of TCNS in the studied groups
Demonstrate the findings of Toronto clinical neuropathy scale in the studied groups, to screen for the neuropathic symptoms where overall scores of 6 and more are considered positive.
Measured: through study completion, an average of 9 months
Demonstrate the findings of EuroQOL-5D-5L in the studied groups
Demonstrate the findings of Euro quality of life -5 dimensions -5 levels scale in the studied groups, where lesser scores suggest a lower overall quality of life.
Measured: through study completion, an average of 9 months
Demonstrate the findings of nerve conduction studies protocol of the performed nerves in the studied groups.
Demonstrate the findings of nerve conduction studies (NCS) to define neuropathy in the studied groups, which include: unilateral sensory studies of sural, superficial peroneal and ulnar nerves, and motor studies of tibial, peroneal, and ulnar motor nerves with ulnar and tibial F wave latencies. Nerves were evaluated according to a recommended protocol for NCS postulated by the American Academy of Neurology in conjunction with the American Association of Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation, which include an abnormality of any nerve conduction attribute is in two separate nerves, one of which must be the sural nerve.
Measured: through study completion, an average of 9 months
Demonstrate the findings of cutaneous silent period in the studied groups.
Demonstrate the findings of cutaneous silent period on stimulating left median nerve and recording from the left abductor pollicis brevis muscle, and on stimulating right sural nerve and recording from the tibialis anterior muscle, where abnormal results in encountered when there is delayed onset and/or end latencies, and/or decreased or absent duration.
Measured: through study completion, an average of 9 months
Demonstrate the findings of sympathetic skin response in the studied groups.
Demonstrate the findings of sympathetic skin response on hand-to-hand stimulation of both median nerves, and foot-to-foot stimulation of both tibial nerves, where abnormal result is encountered when there is absent response, or delayed onset latency and/or decreased amplitude.
Measured: through study completion, an average of 9 months
Demonstrate the findings of Ewing battery in the studied groups.
Demonstrate the findings of Ewing battery in the studied groups, where findings are recorded in all the 5 domains of the battery as normal or borderline or abnormal. Total score ranges from 0-5, and cardiovascular autonomic neuropathy is diagnosed according to the findings o fthe battery, where the findings are classified as follows
- Normal: If all tests are normal, or one test is borderline.
- Early: One heart rate test is abnormal or two are borderline.
- Definite: At least two heart rate tests are abnormal
- Severe: At least two heart rate tests are abnormal plus either at least one blood pressure test is abnormal or both tests are borderline.
- Atypical: Any other undefined combination.
Further simplified classification is either normal (including normal or early findings) and abnormal (including definite, severe and atypical findings).
Measured: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound CSA of both vagal nerves.
Demonstrate the findings of nerve ultrasound cross-sectional area of both vagal nerves scanned opposite to the cricoid cartilage in the studied groups.
Measured: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound CSA of right sural nerve.
Demonstrate the findings of nerve ultrasound cross-sectional area of right sural nerve at the distal calf in the studied groups.
Measured: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound CSA of left tibial nerve.
Demonstrate the findings of nerve ultrasound cross-sectional area of left tibial nerve at the distal calf in the studied groups.
Measured: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound CSA of left median nerve.
Demonstrate the findings of nerve ultrasound cross-sectional area of left median nerve at the mid-forearm in the studied groups.
Measured: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound CSA of right ulnar nerve.
Demonstrate the findings of nerve ultrasound cross-sectional area of right ulnar nerve at the mid-forearm in the studied groups.
Measured: through study completion, an average of 9 months
Secondary outcomes (4)
Diabetic neuropathy severity assessment using NPS
Diabetic neuropathy severity assessment using 11-item Numeric Pain Scale overall score.
Measured: through study completion, an average of 9 months
Diabetic neuropathy severity assessment TCNS
Diabetic neuropathy severity assessment using Toronto clinical neuropathy scale, overall score.
Measured: through study completion, an average of 9 months
Diabetic neuropathy severity assessment using COMPASS-31
Diabetic neuropathy severity assessment using The Composite Autonomic Symptom Score-31, overall score.
Measured: through study completion, an average of 9 months
Diabetic neuropathy quality of life evaluation using Euro quality of life -5 dimensions -5 levels scale.
Diabetic neuropathy quality of life evaluation using EuroQOL-5D-5L index value.
Measured: through study completion, an average of 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sami Alkotami, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993871
- Sponsor's protocol ID
- 34059/8/20
- Status last verified
- Apr 2024
- First submitted
- 21 May 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Devigili G, Tugnoli V, Penza P, Camozzi F, Lombardi R, Melli G, Broglio L, Granieri E, Lauria G. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain. 2008 Jul;131(Pt 7):1912-25. doi: 10.1093/brain/awn093. Epub 2008 Jun 4.
PubMed 18524793Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
PubMed 20876709Tankisi H, Pugdahl K, Beniczky S, Andersen H, Fuglsang-Frederiksen A. Evidence-based recommendations for examination and diagnostic strategies of polyneuropathy electrodiagnosis. Clin Neurophysiol Pract. 2019 Nov 18;4:214-222. doi: 10.1016/j.cnp.2019.10.005. eCollection 2019.
PubMed 31886447Singleton JR, Bixby B, Russell JW, Feldman EL, Peltier A, Goldstein J, Howard J, Smith AG. The Utah Early Neuropathy Scale: a sensitive clinical scale for early sensory predominant neuropathy. J Peripher Nerv Syst. 2008 Sep;13(3):218-27. doi: 10.1111/j.1529-8027.2008.00180.x.
PubMed 18844788Terkawi AS, Abolkhair A, Didier B, Alzhahrani T, Alsohaibani M, Terkawi YS, Almoqbali Y, Tolba YY, Pangililan E, Foula F, Tsang S. Development and validation of Arabic version of the douleur neuropathique 4 questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S31-S39. doi: 10.4103/sja.SJA_97_17.
PubMed 28616002Eldokla AM, Mohamed-Hussein AA, Fouad AM, Abdelnaser MG, Ali ST, Makhlouf NA, Sayed IG, Makhlouf HA, Shah J, Aiash H. Prevalence and patterns of symptoms of dysautonomia in patients with long-COVID syndrome: A cross-sectional study. Ann Clin Transl Neurol. 2022 Jun;9(6):778-785. doi: 10.1002/acn3.51557. Epub 2022 Apr 8.
PubMed 35393771Ewing DJ, Martyn CN, Young RJ, Clarke BF. The value of cardiovascular autonomic function tests: 10 years experience in diabetes. Diabetes Care. 1985 Sep-Oct;8(5):491-8. doi: 10.2337/diacare.8.5.491.
PubMed 4053936Bril V, Perkins BA. Validation of the Toronto Clinical Scoring System for diabetic polyneuropathy. Diabetes Care. 2002 Nov;25(11):2048-52. doi: 10.2337/diacare.25.11.2048.
PubMed 12401755Sletten DM, Suarez GA, Low PA, Mandrekar J, Singer W. COMPASS 31: a refined and abbreviated Composite Autonomic Symptom Score. Mayo Clin Proc. 2012 Dec;87(12):1196-201. doi: 10.1016/j.mayocp.2012.10.013.
PubMed 23218087Al Shabasy S, Abbassi M, Finch A, Roudijk B, Baines D, Farid S. The EQ-5D-5L Valuation Study in Egypt. Pharmacoeconomics. 2022 Apr;40(4):433-447. doi: 10.1007/s40273-021-01100-y. Epub 2021 Nov 17.
PubMed 34786590Bekairy AM, Bustami RT, Almotairi M, Jarab A, Katheri AM, Aldebasi TM, Aburuz S. Validity and reliability of the Arabic version of the the EuroQOL (EQ-5D). A study from Saudi Arabia. Int J Health Sci (Qassim). 2018 Mar-Apr;12(2):16-20.
PubMed 29599689Vetrugno R, Liguori R, Cortelli P, Montagna P. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003 Aug;13(4):256-70. doi: 10.1007/s10286-003-0107-5.
PubMed 12955550Lauria G, Hsieh ST, Johansson O, Kennedy WR, Leger JM, Mellgren SI, Nolano M, Merkies IS, Polydefkis M, Smith AG, Sommer C, Valls-Sole J; European Federation of Neurological Societies; Peripheral Nerve Society. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on the use of skin biopsy in the diagnosis of small fiber neuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society. Eur J Neurol. 2010 Jul;17(7):903-12, e44-9. doi: 10.1111/j.1468-1331.2010.03023.x.
PubMed 20642627Telleman JA, Herraets IJ, Goedee HS, van Asseldonk JT, Visser LH. Ultrasound scanning in the diagnosis of peripheral neuropathies. Pract Neurol. 2021 Jun;21(3):186-195. doi: 10.1136/practneurol-2020-002645. Epub 2021 Feb 4.
PubMed 33541914Tawfik EA, Walker FO, Cartwright MS, El-Hilaly RA. Diagnostic Ultrasound of the Vagus Nerve in Patients with Diabetes. J Neuroimaging. 2017 Nov;27(6):589-593. doi: 10.1111/jon.12452. Epub 2017 May 19.
PubMed 28524416
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study
- ClinicalTrials.gov ID
- NCT05993871
- Acronym / sponsor ID
- 34059/8/20
- Conditions
- Small Fiber Neuropathy, Diabetic Neuropathies, Autonomic Neuropathy, Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy, Diabetic Polyneuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This case-control observational study is aiming to evaluate patients with diabetic small fiber neuropathy in the Egyptian.
Diabetic small fiber neuropathy was defined as both of the following:
- Typical clinical symptoms of SFN such as burning or sharp pain in toes and feet, and on clinical examination: loss of small fiber modalities (pinprick and temperature), hyperalgesia, allodynia, and/or autonomic signs.
- Reduced intraepidermal nerve fiber density (IENFD) in distal leg skin punch biopsy.
The study includes 3 groups:
Group I: Patients with diabetic small fiber neuropathy Group II (Control Group): Patients with diabetic mixed small and large fiber neuropathy Group III (Control Group): Subjects without peripheral neuropathy
Clinical evaluation includes: Neuropathic Pain 4 (DN4) questionnaire, 11-point Numeric Pain Scale (NPS), Utah Early Neuropathy Scale (UENS), Toronto Clinical Neuropathy Scale (TCNS), Composite Autonomic Symptom Score (COMPASS-31), an Arabic version, and several anthropometric measures; including: body weight in kilograms, height in centimeters, waist circumference measured in centimeters at the top of the iliac crest, and systolic "SBP" and diastolic "DBP" blood pressure measurement in mmHg.
Electrodiagnostic evaluation includes: routine nerve conduction study, cutaneous silent period by stimulating left median nerve and right sural nerve and recording from the abductor pollicis brevis and tibialis anterior muscles, respectively, bilateral hand-to hand and foot-to-foot sympathetic skin response, and Ewing battery using R-R interval analysis, in addition to the blood pressure tests.
Neurosonographic evaluation includes: bilateral vagal nerve scan at the mid-neck lateral to the thyroid cartilage, left median and right ulnar nerves scan at the mid-forearm, left tibial nerve at the distal ankle 2 to 4 fingerbreadths proximal to the medial malleolus, and right sural nerve 2 to 4 fingerbreadths proximal to the lateral malleolus. Nerves are evaluated for transverse cross-sectional area (CSA).
Severity and outcome measures are assessed using: NPS, TCNS, COMPASS-31, and the index score of Euro Quality of Life -5 Dimensions -5 Levels (EuroQOL-5D-5L), the Arabic version.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetic small fiber neuropathy | – | Diagnostic Test: Clinical Evaluation/Questionnaires, Diagnostic Test: Nerve Conduction Study, Diagnostic Test: Small fiber electrodiagnostic tests, Diagnostic Test: Nerve Ultrasound, Diagnostic Test: Skin BiopsyDiabetic Patients presented with pure small fiber neuropathy. |
| Patients with diabetic mixed small and large fiber neuropathy | – | Diagnostic Test: Clinical Evaluation/Questionnaires, Diagnostic Test: Nerve Conduction Study, Diagnostic Test: Small fiber electrodiagnostic tests, Diagnostic Test: Nerve Ultrasound, Diagnostic Test: Skin BiopsyDiabetic Patients presented with mixed small and large fiber neuropathy |
| Subjects without neuropathy | – | Diagnostic Test: Clinical Evaluation/Questionnaires, Diagnostic Test: Nerve Conduction Study, Diagnostic Test: Small fiber electrodiagnostic tests, Diagnostic Test: Nerve Ultrasound, Diagnostic Test: Skin BiopsyHealthy subjects without any symptoms and/or signs suggesting neuropathy, and within average IENFD on skin biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group I: Patients with diabetic small fiber neuropathy Group II: Patients with diabetic mixed small and large fiber neuropathy Group III: Subjects without neuropathy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
- Atrial Fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Evaluation/QuestionnairesAnthropometric measures, somatosensory assessment (NPS, UENS, TCNS), autonomic assessment (COMPASS-31, Ewing battery), and severity and quality of life evaluation (NPS, TCNS, COMPASS-31, and EuroQOL-5D-5L index score) | Diagnostic test | Patients with diabetic mixed small and large fiber neuropathy, Patients with diabetic small fiber neuropathy, Subjects without neuropathy |
| Nerve Conduction StudyRoutine Nerve Conduction Study. | Diagnostic test | Patients with diabetic mixed small and large fiber neuropathy, Patients with diabetic small fiber neuropathy, Subjects without neuropathy |
| Small fiber electrodiagnostic testsR-R interval analysis, Cutaneous Silent Period and Sympathetic Skin Response. | Diagnostic test | Patients with diabetic mixed small and large fiber neuropathy, Patients with diabetic small fiber neuropathy, Subjects without neuropathy |
| Nerve UltrasoundBilateral vagal, left median, right ulnar, left tibial and right sural nerves ultrasound. | Diagnostic test | Patients with diabetic mixed small and large fiber neuropathy, Patients with diabetic small fiber neuropathy, Subjects without neuropathy |
| Skin Biopsydistal leg 3mm punch skin biopsy | Diagnostic test | Patients with diabetic mixed small and large fiber neuropathy, Patients with diabetic small fiber neuropathy, Subjects without neuropathy |
Primary outcome
Demonstrate the findings of UENS in the studied groups
Time frame: through study completion, an average of 9 months
Demonstrate the findings of Utah early neuropathy scale in the studied groups to screen for neuropathic symptoms, where overall scores of 4 and more are considered positive.
Demonstrate the findings of TCNS in the studied groups
Time frame: through study completion, an average of 9 months
Demonstrate the findings of Toronto clinical neuropathy scale in the studied groups, to screen for the neuropathic symptoms where overall scores of 6 and more are considered positive.
Demonstrate the findings of EuroQOL-5D-5L in the studied groups
Time frame: through study completion, an average of 9 months
Demonstrate the findings of Euro quality of life -5 dimensions -5 levels scale in the studied groups, where lesser scores suggest a lower overall quality of life.
Demonstrate the findings of nerve conduction studies protocol of the performed nerves in the studied groups.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of nerve conduction studies (NCS) to define neuropathy in the studied groups, which include: unilateral sensory studies of sural, superficial peroneal and ulnar nerves, and motor studies of tibial, peroneal, and ulnar motor nerves with ulnar and tibial F wave latencies. Nerves were evaluated according to a recommended protocol for NCS postulated by the American Academy of Neurology in conjunction with the American Association of Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation, which include an abnormality of any nerve conduction attribute is in two separate nerves, one of which must be the sural nerve.
Demonstrate the findings of cutaneous silent period in the studied groups.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of cutaneous silent period on stimulating left median nerve and recording from the left abductor pollicis brevis muscle, and on stimulating right sural nerve and recording from the tibialis anterior muscle, where abnormal results in encountered when there is delayed onset and/or end latencies, and/or decreased or absent duration.
Demonstrate the findings of sympathetic skin response in the studied groups.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of sympathetic skin response on hand-to-hand stimulation of both median nerves, and foot-to-foot stimulation of both tibial nerves, where abnormal result is encountered when there is absent response, or delayed onset latency and/or decreased amplitude.
Demonstrate the findings of Ewing battery in the studied groups.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of Ewing battery in the studied groups, where findings are recorded in all the 5 domains of the battery as normal or borderline or abnormal. Total score ranges from 0-5, and cardiovascular autonomic neuropathy is diagnosed according to the findings o fthe battery, where the findings are classified as follows * Normal: If all tests are normal, or one test is borderline. * Early: One heart rate test is abnormal or two are borderline. * Definite: At least two heart rate tests are abnormal * Severe: At least two heart rate tests are abnormal plus either at least one blood pressure test is abnormal or both tests are borderline. * Atypical: Any other undefined combination. Further simplified classification is either normal (including normal or early findings) and abnormal (including definite, severe and atypical findings).
Demonstrate the findings of nerve ultrasound CSA of both vagal nerves.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound cross-sectional area of both vagal nerves scanned opposite to the cricoid cartilage in the studied groups.
Demonstrate the findings of nerve ultrasound CSA of right sural nerve.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound cross-sectional area of right sural nerve at the distal calf in the studied groups.
Demonstrate the findings of nerve ultrasound CSA of left tibial nerve.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound cross-sectional area of left tibial nerve at the distal calf in the studied groups.
Demonstrate the findings of nerve ultrasound CSA of left median nerve.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound cross-sectional area of left median nerve at the mid-forearm in the studied groups.
Demonstrate the findings of nerve ultrasound CSA of right ulnar nerve.
Time frame: through study completion, an average of 9 months
Demonstrate the findings of nerve ultrasound cross-sectional area of right ulnar nerve at the mid-forearm in the studied groups.
4 secondary outcomes
Diabetic neuropathy severity assessment using NPS
Time frame: through study completion, an average of 9 months
Diabetic neuropathy severity assessment TCNS
Time frame: through study completion, an average of 9 months
Diabetic neuropathy severity assessment using COMPASS-31
Time frame: through study completion, an average of 9 months
Diabetic neuropathy quality of life evaluation using Euro quality of life -5 dimensions -5 levels scale.
Time frame: through study completion, an average of 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 18524793Devigili G, Tugnoli V, Penza P, Camozzi F, Lombardi R, Melli G, Broglio L, Granieri E, Lauria G. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain. 2008 Jul;131(Pt 7):1912-25. doi: 10.1093/brain/awn093. Epub 2008 Jun 4.
- Background: PubMed 20876709Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
- Background: PubMed 31886447Tankisi H, Pugdahl K, Beniczky S, Andersen H, Fuglsang-Frederiksen A. Evidence-based recommendations for examination and diagnostic strategies of polyneuropathy electrodiagnosis. Clin Neurophysiol Pract. 2019 Nov 18;4:214-222. doi: 10.1016/j.cnp.2019.10.005. eCollection 2019.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Fiber Neuropathy and Diabetic Neuropathies, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the findings of UENS in the studied groups (time frame: through study completion, an average of 9 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993871, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.