RISCAID Study: Remote ISchemic Conditioning for Angiopathy In Diabetes

NCT02749942 | Completed DMC

• 1 other identifier: RISCAID
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes; Remote Ischemic Conditioning; Neuropathy; Angiopathy

Outcome Measures

Primary Outcomes (1)

• Peripheral tissue oxygen oxygenation of dorsal part of foot

  Transcutaneous oxygen tension

  Change from baseline to 12 weeks of treatment

Secondary Outcomes (13)

• Toe Pressure

  At baseline and fter 12 weeks of treatment and 4 weeks post treatment

• Central vasculopathy

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

• Glycocalyx assessment

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

• Cardiovascular autonomic neuropathy, E/I ratio

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

• Peripheral autonomic function

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

Other Outcomes (29)

• Serum markers of inflammation, 1

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

• Serum markers of vascular function, 1

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

• Serum markers of kidney function

  At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment

Study Arms (2)

AutoRIC: Remote Ischemic Conditioning

ACTIVE COMPARATOR

Daily cuff treatment of arm with 4 cycles of 5 minute forearm ischemia/reperfusion (200 mmHG of pressure) on top of standard care.

Device: AutoRIC: Remote Ischemic Conditioning

AutoRIC: Sham device treatment

SHAM COMPARATOR

Daily sham device treatment of arm, 4 cycles of 5 minute (0 mmHG of pressure) on top of standard care. No ischemia induced.

Device: AutoRIC: Sham device treatment

Interventions

AutoRIC: Remote Ischemic Conditioning DEVICE

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

AutoRIC: Remote Ischemic Conditioning

AutoRIC: Sham device treatment DEVICE

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

AutoRIC: Sham device treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Age 40-80
• Complaints of claudication or reduced walking distance compared to equals
• Toe pressure from 40 mmHG to 70 mmHg

You may not qualify if:

• Foot ulcer
• Peripheral gangrene or infection
• Toe pressure \< 40 mmHg or \> 90 mmHg
• Heart failure
• Pregnancy
• Treatment with anti-platelet drugs besides acetylsalicylic acid
• Cancer
• Chronic obstructive pulmonary disease

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Aarhus University Hospital: collaborator
• German Diabetes Center: collaborator

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

• Hansen CS, Jorgensen ME, Fleischer J, Botker HE, Rossing P. Efficacy of Long-Term Remote Ischemic Conditioning on Vascular and Neuronal Function in Type 2 Diabetes Patients With Peripheral Arterial Disease. J Am Heart Assoc. 2019 Jul 2;8(13):e011779. doi: 10.1161/JAHA.118.011779. Epub 2019 Jun 19.

  PMID: 31215299 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Peter Rossing, Professor

  Head of department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 25, 2016
• Study Start: May 11, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 11, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)