Trial · NCT05023889
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Neurological Impairment Score | baseline to 24 months | to assess the severity of functional impairment of motor and sensory nerves.NIS is a measure of motor strength, comprised of cranial nerve and both upper and lower limb motor assessments. The minimum and maximum values are 0 and 192, respectively. A higher score indicates a worse outcome. |
| Primary | Norfolk QOL-DN | baseline to 24 months | Change in Norfolk Quality of Life Questionnaire (Norfolk QOL-DN).The change from baseline in Norfolk QoL-DN at 24 months. The Norfolk QoL-DN questionnaire is a standardized 35-item patient-reported outcomes measure of diabetic neuropathy - small fiber, large fiber, and autonomic nerve function. The minimum and maximum values are -4 and 136, respectively. A higher score indicates a worse outcome. |
| Primary | COMPASS 31score | baseline to 24 months | Composite Autonomic Symptom Score (COMPASS) 31a self-assessment instrument for patient reported autonomic symptoms such as dizziness, constipation, diarrhea, nausea/vomiting, and incontinence. The minimum and maximum values are 0 and 100, respectively. A higher score indicates a worse outcome |
| Secondary | PND Polyneuropathy disability (PND) Score | baseline to 24 months | To compare and identify changes. Stage 0: no impairment Stage I: sensory disturbances but preserved walking capability Stage II: impaired walking capability but ability to walk without a stick or crutches Stage III a: walking only with the help of one stick or crutch Stage III b: walking with the help of two sticks or crutches. V: confined to wheelchair or bedridden A higher score indicates a worse outcome. |
| Secondary | Karnofsky, performance status score | baseline to 24 months | Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. |
| Secondary | EuroQOL | baseline to 24 months | EuroQOL,- A measurement tool that assesses generic quality of life in mobility, self-care, usual activities, pain/discomfort, anxiety/depression The minimum and maximum values are 0 and 100, respectively. A higher score indicates a worse outcome. |
| Secondary | EMG -Electromyography | baseline to 24 months | (EMG) is a diagnostic test that measures how the muscles and nerves work to evaluate peripheral Neuropathies pattern and progression |
| Secondary | Tilt Table Test | 24 months | Evaluate and compare the response of blood pressure and heart rate changes in posture and position. |
| Secondary | Optional exploratory nerve and muscle biopsy | during screening visit ( 28 day window) | to identify amyloid deposits in skeletal muscle and peripheral nerve |
| Other | Cardiac MRI | start of study, and study end at 2 years | to identify cardiac abnormalities or changes and comparison |
| Other | Echo with strain | start of study, and study end at 2 years | to identify cardiac abnormalities or changes and comparison |
| Other | PYP - mTc99-PYP | start of study, and study end at 2 years | for cardiac amyloidosis imaging. - to identify cardiac function changes and comparison |
| Other | NT Pro BNP blood draw | start of study, and study end at 2 years | serum biomarker to evaluate heart failure severity, ( pg/ml) |
| Other | NFL blood draw | at start, month 1,2,3,6 and every 6 months after until study end at two years | Serum Neurofilament Light Chain level in patients with evolving disease, ( pg/mL) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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