Trial · NCT02878798
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraepidermal Nerve Fiber Density (IENFD) | 96 weeks | Difference in IENFD change between treatment groups over 96 weeks (fibers/mm) (i.e. the slope of change). A skin biopsy is obtained. The sample is stained for nerve fibers. The rate of change in IENFD in fibers/mm is calculated over the 96 week duration of the study and expressed in change in fibers/mm/year (defined as 52 weeks) over the study period (i.e. the slope of change expressed and change in IENFD in fibers/mm over a 52 week period). |
| Primary | Norfolk Quality of Life - Diabetic Neuropathy | 96 weeks (expressed as a slope in change of total score/52 weeks) | Difference in NQOL between treatment groups over 96 weeks. The Norfolk QOL-DN is a validated 47-item, patient-reported outcome measure, sensitive to the different features of diabetic neuropathy (DN) including small fiber, large fiber, and autonomic function. A lower score is better. The range of the score is from -4 to 136. The slope of the change in total Norfolk QOL-DD is calculated as the change in total score/52 weeks (one year) |
| Secondary | Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference | 96 weeks (expressed as a change in change in pain interference/52weeks) | Pain interference score. Each item is scored from 0-10 with a total possible number of points of 70, higher worse. The range of the score is 0-70. The change in score is expressed as a slope of change in pain interference score/52 weeks (one year) |
| Secondary | Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity | 96 weeks (expressed as a slope of change over 52 weeks) | Average pain severity. Each item is scored 0-10 with a total of 40 possible points, higher is worse. The range of the score is 0-40. The slope of the change in this score is expressed as change/one year (defined as 52 weeks) |
| Secondary | Utah Early Neuropathy Scale | 96 weeks (expressed as a slope of change in total UENS over 52 weeks). | The UENS is a validated examination score of neuropathy severity based on a physical examination (Singleton et al 2008). Total score is 42 (minimum 0 and maximum 42). The higher the score, the worse the outcome is. The change in UENS over the 96 week period is expressed as a slope of change in total UENS over one year defined as 52 weeks. |
| Secondary | Sural Sensory Amplitude (SSA) | 96 weeks (slope of change in mV/52weeks) | Change in SSA measured in microvolts. SSA is measured by electrically stimulating a nerve through the skin and recording the response. A larger value is better. The normal values vary based on age, with a minimum of 0 (absent). Across all ages, the lower limit of normal is 6 microvolts, although the normal cutoff declines with aging. The change in SSA over the 96 week study period is expressed as a slope of change in uV/52 weeks (the 52 week log (mV) change of non-zero values). |
| Secondary | Peroneal Motor Conduction Velocity (PMCV) | 96 weeks (expressed as a slope of change in meter/sec over 52 weeks) | PMCV change. PMCV is measured by electrically stimulating the nerve through the skin at two different locations and measuring how fast the response travels between the two in meters/second. A higher value is better. The slope of the change in PMCV is expressed as change in meters/second/52 weeks (one year). |
| Secondary | Body Mass Index (BMI) | 96 weeks (slope of change in kg/m2/52 weeks) | BMI change in kg/m2. BMI is a measure of weight relative to height. The slope of the change in BMI over the study was expressed as change in kg/m2/52 weeks. |
| Secondary | Hemoglobin A1C | The annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weeks | Slope of the Hemoglobin A1C change. A1C is measured in percent. It provides an estimate of how high blood sugar has been over the past three months. A higher value indicates poor diabetic control. |
| Secondary | Serum Triglycerides (TRG) | 96 weeks (slope of change mg/dl over 52 weeks) | TRG change. TRG are a type of lipid or fat circulating in the blood. A higher value is associated with increased cardiovascular risk. The slope of the change in TRG was calculated as change in mg/dl over 52 weeks (one year). |
| Secondary | LDL Cholesterol | 96 weeks (expressed as a slope of change in mg/dl/52 weeks) | LDL change. LDL is "bad" cholesterol, measured in mg/dL. A higher value is associated with elevated cardiovascular risk. A slope of change is calculated change in LDL in mg/dL/52 weeks (one year) |
| Secondary | HDL Cholesterol | 96 weeks (expressed as slope of change in mg/dL/52 weeks) | HDL change. HDL is "good cholesterol", measured in mg/dL. A lower value is associated with higher cardiovascular risk. The slope of change is calculated as change in mg/dL/52 weeks (one year) |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02878798/registered