check_circleStudy Completed

Diabetic foot

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

All

Age

55 - 75 Years

Trial summary

Enrollment Goal
23
Trial Dates
May 2017 - October 2019
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY1193397
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Devon & Exeter HospitalExeter, 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 administration
    date_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 administration
    date_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 administration
    date_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 administration
    date_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 severity
    date_rangeTime Frame:
    From first application of study medication up to 2 days after end of treatment with study medication

Trial design

A randomized, single-blind, threefold crossover, single-center study to assess the safety and the effects of 1 mg and 5 mg BAY1193397 in comparison to placebo on skin capillary blood flow and transcutaneous oxygen pressure after single dose in type II diabetic patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
3