| Trial ID: | L4946 |
| Source ID: | NCT02936843
|
| Associated Drug: |
Salsalate
|
| Title: |
Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy
|
| Acronym: |
TINSAL-T1DN
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Peripheral Neuropathy
|
| Interventions: |
DRUG: Salsalate|DRUG: PLACEBO
|
| Outcome Measures: |
Primary: Skin Biopsy - Intraepidermal Nerve Fiber Density (IENFD) - Distal Thigh, Change from baseline to month 12 in the intraepidermal nerve fiber density. IENFD, is a continuous measure of small fiber neuropathy, with high positive and negative predictive values along with a high diagnostic efficiency in differentiating between subjects with and without neuropathy. The morphometric quantification of IENFD, most commonly expressed as the number of IENFs per length of section (IENF/mm e.g. density) is possible with skin biopsy (IENFD) at the distal thigh., 12 months |
|
| Sponsor/Collaborators: |
Sponsor: University of Michigan
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
61
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-10
|
| Completion Date: |
2023-05-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-07-10
|
| Locations: |
Veterans Administration Ann Arbor Health Center, Ann Arbor, Michigan, 48105, United States|University of Michigan Health System, Ann Arbor, Michigan, 48109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02936843
|
