Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Balance From Baseline to 4 Weeks
研究概览
简要总结
Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene.
A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc).
The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female , age 18 or older with the ability and willingness to provide Informed consent
- •Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study
- •History of type 2 diabetes confirmed by patient's physician.
- •History of peripheral neurpathy .
排除标准
- •Patients with severe peripheral vascular disease (ankle-brachial systolic pressure index (ABI) <0.5 or ABI>1.30)
- •Patients with active wound infection, or untreated osteomyelitis
- •Patients with major foot deformities (e.g. Charcot Foot) or major amputation (e.g. above ankle)
- •Unamulatory of those who are unable to independently walk with or without walking assistance, a distance of 40 feet.
- •Patients who are unable or unwilling to participate in all procedures and follow up evaluations
- •Patients currently on immunosuppressive drugs.
- •Pregnant or breast feeding ladies.
结局指标
主要结局
Change in Balance From Baseline to 4 Weeks
时间窗: baseline and 4 weeks.
Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm.
Change in Skin Perfusion From Baseline to 4 Weeks
时间窗: Baseline and 4 weeks
Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg.
次要结局
- Change in Lower Extremity Edema From Baseline to 4 Weeks(Baseline and 4 weeks)
- Change in Stride Velocity From Baseline to 4-week(Baseline to 4 weeks)
- Change in Plantar Sensation From Baseline to 4-week(Baseline to 4 weeks)
研究者
Bijan Najafi, PhD
Professor of Surgery
Baylor College of Medicine