The effects of BAY 1193397 on skin capillary blood flow
Research type
Research Study
Full title
A randomized, single blind, threefold crossover, single center study to assess the safety and the effects of 1 mg and 5 mg BAY 1193397 in comparison to placebo on skin capillary blood flow and transcutaneous oxygen pressure after single dose in type II diabetic patients with peripheral artery disease
IRAS ID
199124
Contact name
William David Strain
Contact email
Sponsor organisation
Bayer AG
Eudract number
2015-003799-63
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
The purpose of this study is to test a new drug BAY 1193397, which is being developed for the treatment of foot ulcers in people with diabetes mellitus. The drug is not available yet, and will need to be tested in a number of different clinical studies like this one before receiving marketing approval.
This study will be investigating the effects of BAY 1193397 on the blood flow in the small blood vessels in the big toes of diabetic participants with peripheral artery disease. The safety and tolerability of BAY 1193397 will also be analysed in this study.
This study will be the first study in diabetic participants. The aim of this study is to analyse the blood flow in small blood vessels (capillaries) in diabetic participants before and after two different single doses of BAY 1193397 (1 mg and 5 mg tablets) and placebo. In order to see if the study drug works, BAY 1193397 tablets will be compared to placebo tablets. Placebo tablets are dummy tablets which look exactly like the study drug but do not contain any active substance active ingredients.
The study involves five scheduled visits to the clinic and it is expected that participants will take part in the study for no more than nine weeks. Participants will undergo a number of tests including examination of the big toe through a microscope, ECGs, blood vessel functions tests, blood tests and physical examinations.
About 18 participants, aged between 55 and 75, are planned to participate in this study at the Royal Devon and Exeter Medical Hospital.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0062
Date of REC Opinion
21 Mar 2017
REC opinion
Further Information Favourable Opinion