RISCAID: Remote ISchemic Conditioning for Angiopathy In Diabetes

Peripheral arterial disease (PAD) is a vast socioeconomic challenge in the community of diabetes patients, causing foot ulcers and lower extremity amputations. The main treatment option for the complication is operative revascularisation. Thus there is a need for new treatment modalities for diabetes patients with PAD. 

Remote ischemic conditioning (RIC) is at non-invasive non-pharmacological treatment which has been shown to attenuate tissue damage caused by ischemia e.g. in hearts subjected to ischemia. RIC treatment consists of brief repetitive periods of ischemia induced in an extremity e.g. an arm. Recent findings show that six week RIC treatment improves healing of diabetic foot ulcers, suggesting a possible effect on the underlying pathological causes of ulcers e.g. PAD.    

Aim

The overall aim of this study is to investigate if long-term ambulatory remote ischemic conditioning can improve symptoms and signs of peripheral arterial disease and neuropathy in patients with type 2 diabetes. 

Design and method

a single center double-blinded randomized placebo controlled study investigating the efficacy of home based 12-week RIC treatment on markers of vascular, neuronal function, inflammation and serum lipid composition in 40 type 2 diabetes patients from Steno Diabetes Center with non-critical PAD.  

Target group
Type 2 diabetes patients age 40-80 with moderate peripheral arterial disease (toe pressure from 40 mmHG to 70 mmHg)

Expected ending and outcome
The study will generate data for 3-4 publications and serve as a base for evaluation of the feasibility of a full scale study with walking distance as primary outcome. 
Study end: spring 2017

Collaborators
Peter Rossing, professor, MD at the complication group, Steno Diabetes Center has many years of experience with clinical trials in the field of diabetic cardiovascular complications. Peter has a broad international network of research collaborators. Peter will ensure that the RCT setup is of the highest standards and contribute with his vast knowledge of the assessment of micro- and microvascular disease. He will also contribute to the overall interpretation of the study results. Peer-reviewed publications > 280. 

Marit Eika Jørgensen, professor, MD, head of Clinical Epidemiology at Steno Diabetes Center has an extensive knowledge in the field of early detection and prevention of diabetes related complications in large scale studies both nationally and internationally. Peer-reviewed publications > 80, > 50 articles were published since 2012.

Martin Ridderstråle, professor, MD, has many years of experience in RCTs in both Sweden and Denmark and has run several international RCTs trials. Martin also has a wide range of international and national collaborators. Martins will contribute to the project by facilitating the collaboration with the outpatient clinic and the laboratory and in addition ensuring that the study set up is feasible and the scientific quality is of high class. Martin will also contribute to the interpretation of the result of the trial. Peer-reviewed publications > 70. 

Christian Stevns Hansen, MD, PhD-student has published papers on both endothelial function and diabetic neuropathy and has extensive knowledge in these areas. Christian will perform the majority of the clinical measurements, analyse the data and write 3-4 articles based on the study. Christian has research experience in randomised controlled trials, clinical implementation of medical devices and expert knowledge in the fields of cardiology and diabetic neurology. Peer-reviewed publications = 5. 

Hans Erik Bøtker, MD, Cardiologist, professor at Skeiby University Hospital – a pioneer in prehospital RIC treatment of angina. Has expert knowledge on RIC treatment in both acute and outpatient clinical settings. Hans Henrik will contribute to the study by consulting on the use of RIC, evaluating the study setup, and interpreting the results of the trial. Peer-reviewed publications > 290.

Christian Herder, assistant professor, PhD, MSc, German Diabetes Center, Dusseldorf, Germany, will be handling biological material for analyses of inflammation and will be involved in the interpretation of these data. Peer-reviewed publications > 230. 

Dan Ziegler, MD, professor, institute for Clinical Diabetology, will in collaboration with professor Michael Roden perform the analyses on oxidative stress and endothelial dysfunction. Hi will be a part of the manuscript writing in relation to these markers and also help interpret results on neuropathy outcomes diabetic neuropathy is one of his fields of expertise.  Peer-reviewed publications > 110

Michael Roden professor, dr. head of institute for Clinical Diabetology, will in collaboration with professor Dan Ziegler  perform the analyses on oxidative stress and endothelial dysfunction. He will be a part of the manuscript writing in relation to these marker and also help interpret results on vascular function as he has diabetic angiopathy is one of his fields of expertise .  Peer-reviewed publications > 400.

Sidst opdateret 07-06-2016

Responsible
Peter Rossing
Professor MD

Christian Stevns Hansen
MD Post. Doc