RISCAID Study: Remote ISchemic Conditioning for Angiopathy In Diabetes

Summary

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

Background 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.

Hypothesis The investigators hypothesize that RIC treatment can improve markers of inflammation, vascular and neuronal function and the sense of empowerment in type 2 diabetes patients with reduced peripheral blood supply.

Aim to conduct 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.

to qualitatively investigate the experience of empowerment related to the use of Remote Ischemic Conditioning (RIC) treatment and the mechanisms affecting if and how participants take up the RIC treatment.

Conditions

• Peripheral Arterial Disease

Interventions

DEVICE

AutoRIC: Remote Ischemic Conditioning

4 cycles of 5 minute forearm ischemia/reperfusion (200 mmHG) using the reusable fully automated RIC device "AutoRIC" from CellAegis Devices, Canada

DEVICE

AutoRIC: Sham device treatment

4 cycles of 5 minute forearm sham treatment (no ischemia/reperfusion, 0 mmHG pressure) with the reusable fully automated RIC device "AutoRIC" from CellAegis Devices, Canada

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• German Diabetes Center

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  lead OTHER

Principal Investigators

• Peter Rossing, Professor · Head of department

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-11

Primary Completion

2017-07-01

Completion

2017-07-11

Countries

• Denmark

Study Locations