check_circleStudy Completed
Diabetic foot
Bayer Identifier:
17500
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
The effects of BAY1193397 on skin capillary blood flow and transcutaneous oxygen pressure
Trial purpose
The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of safety and tolerability are secondary objectives of this study.
Key Participants Requirements
Sex
AllAge
55 - 75 YearsTrial summary
Enrollment Goal
23Trial Dates
May 2017 - October 2019Phase
Phase 2Could I Receive a placebo
YesProducts
BAY1193397Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Royal Devon & Exeter Hospital | Exeter, EX2 5AX, United Kingdom |
Primary Outcome
- Change in resting capillary blood flow velocity (CBV)= resting CBV after study drug administration – resting CBV before study drug administrationdate_rangeTime Frame:Before and after treatment with study drug (within 1-3 hours after treatment with study drug)
- Change in peak CBV during reactive hyperemia= peak CBV after study drug administration – peak CBV before study drug administrationdate_rangeTime Frame:Before and after treatment with study drug (within 1-3 hours after treatment with study drug)
- Change in time to peak CBV during reactive hyperemia= time to peak CBV after study drug administration – time to peak CBV before study drug administrationdate_rangeTime Frame:Before and after treatment with study drug (within 1-3 hours after treatment with study drug)
- Change in transcutaneous oxygen pressure (TcPO2)= TcPO2 after study drug administration – TcPO2 before study drug administrationdate_rangeTime Frame:Before and after treatment with study drug (within 1-3 hours after treatment with study drug)
Secondary Outcome
- Number of subjects with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:From first application of study medication up to 2 days after end of treatment with study medication
- Number of subjects with TEAEs in different severitydate_rangeTime Frame:From first application of study medication up to 2 days after end of treatment with study medication
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
3