The RISCAID Study: Remote ISchemic Conditioning for Angiopathy In Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Peripheral tissue oxygen oxygenation of dorsal part of foot
研究概览
简要总结
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.
详细描述
Objective The driving objective of this study is to investigate if long-term ambulatory remote ischemic conditioning can improve symptoms and signs of peripheral arterial disease and the sense of empowerment in patients with type 2 diabetes.
Background Peripheral arterial disease (PAD) is vast challenge in the community of diabetes patients. The prevalence of PAD in diabetes patients exceeds that of non-diabetic individuals and is estimated to be about 26% in diabetes patients over 65 years of age and 71% in patients over 70 years . PAD is the major cause of foot ulcers and lower extremity amputations, which has great socioeconomic implications . The main treatment option for the complication is operative revascularisation which in diabetes patient is associated with increased rates of complication and mortality compared to non-diabetes patients . Pharmacological treatment with e.g. anti-platelet drugs in patients with PAD has shown effect on walking distance has not been indorsed as standard treatment.
Thus there is a need for new treatment options for diabetes patients with PAD. Remote ischemic conditioning (RIC) is a non-invasive non-pharmacological treatment that has been shown to attenuate tissue damage caused by ischemia, reducing infarct size in patients with acute myocardial infarction , reducing organ damage in patient undergoing transplantation and having neuroprotective effects in patients with stroke .
RIC treatment consists of brief repetitive periods of ischemia induced in an extremity e.g. an arm. It is believed that the effect of RIC is mediated through both neuronal and humoral pathways, however the mechanisms behind are not fully understood.
RIC has been shown to have beneficial effects by attenuating platelet activation and aggregation, improving endothelial function , improvement of microcirculation , down-regulation of neutrophil function , down-regulation of inflammatory gene expression , improving mitochondrial function and inducing changes in serum lipid composition One of few long-term RIC treatment studies has shown that twice daily RIC treatment for 300 days is feasible. The study showed that RIC could reduce the recurrence of stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Age 40-80
- •Complaints of claudication or reduced walking distance compared to equals
- •Toe pressure from 40 mmHG to 70 mmHg
排除标准
- •Foot ulcer
- •Peripheral gangrene or infection
- •Toe pressure < 40 mmHg or > 90 mmHg
- •Heart failure
- •Pregnancy
- •Treatment with anti-platelet drugs besides acetylsalicylic acid
- •Chronic obstructive pulmonary disease
研究组 & 干预措施
AutoRIC: Remote Ischemic Conditioning
Daily cuff treatment of arm with 4 cycles of 5 minute forearm ischemia/reperfusion (200 mmHG of pressure) on top of standard care.
干预措施: AutoRIC: Remote Ischemic Conditioning (Device)
AutoRIC: Sham device treatment
Daily sham device treatment of arm, 4 cycles of 5 minute (0 mmHG of pressure) on top of standard care. No ischemia induced.
干预措施: AutoRIC: Sham device treatment (Device)
结局指标
主要结局
Peripheral tissue oxygen oxygenation of dorsal part of foot
时间窗: Change from baseline to 12 weeks of treatment
Transcutaneous oxygen tension
次要结局
- 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)
- Peripheral nerve conduction function(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- Sensory peripheral neuropathy, vibration(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- Sensory peripheral neuropathy, light touch(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- Sensory peripheral neuropathy, pain sensation(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- symptoms of neuropathy(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- Cardiovascular autonomic neuropathy; 30/15 ratio(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- Cardiovascular autonomic neuropathy, Valsalva maneuvre(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
- Cardiovascular Autonomic neuropathy; Heart rate variability(At baseline and 1, 4 and 12 weeks of treatment and 4 weeks post treatment)
研究者
Peter Rossing
Professor
Steno Diabetes Center Copenhagen