Efficacy of a Mild Compression Diabetic Sock Versus A Non- Compression Diabetic Sock in the Control of Lower Extremity Edema in Patients With Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Foot Edema
研究概览
简要总结
The purpose of this study is to determine whether a specially designed sock for people with diabetes and swelling in the legs can reduce the swelling, improve blood flow to the legs, and improve physical activity patterns of those individuals by providing mild compression to their legs.
详细描述
Peripheral arterial disease (PAD) is commonly associated with diabetes. Clinicians are often reluctant to apply compressive stockings to patients with diabetes and swollen legs due to fear of exacerbating the symptoms of PAD. The study sock is a newly formulated sock that offers mild compression (18-25mmHg). The sock is made especially for the diabetic patient who suffers from concomitant lower extremity edema.
Eighty patients with diabetes and lower extremity edema will be recruited. Upon ensuring enrollment criteria are met, baseline edema (as measured by circumference of foot, ankle and calf), ankle brachial index (ABI), skin perfusion pressure, and cutaneous fluid level (as measured by MoistureMeter) will be assessed. Subjects will then be provided four pairs of socks. Subjects will be randomized in a 1:1 distribution to receive either the mild compression diabetic socks or a standard diabetic sock. They will return for four weekly follow up visits.
Additionally a sub-set of 30 subjects will be monitored for changes in physical activity pre and post sock usage. Physical activity monitors will be used to assess daily physical activity for 48hrs prior to receiving the socks and after wearing the socks for four weeks an additional 48hrs will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 with lower extremity edema aged 18 or older with the ability and willingness to provide Informed consent
- •Patient's ankle-brachial systolic pressure index > 0.6 and toe-brachial index > 0.3
- •Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- •Patient has diabetes type 1 or type 2 confirmed by patient's primary care physician.
排除标准
- •Patients with active wound infection, or untreated osteomyelitis, gangrene
- •Patients with dementia, or impaired cognitive function that would prohibit study compliance
- •Patients with wide spread malignancy or systemically immuno-compromising disease
- •Patients who are unable or unwilling to participate in all procedures and follow up evaluations
- •Patient with deep and/or large ulcers that require copious bandaging and may affect efficacy of socks. Patients with superficial ulcers that only require a light dressing are not excluded. The ulcer, if present, must be superficial and cannot exhibit any clinical signs of infection
- •Patients with restless leg syndrome, Parkinson's disease, or other disease that will cause involuntary movement during microvascular assessment
- •Patients with severe edema or calf circumference greater than 24" or 46cm
- •Patients with severe lymphedema
- •Patients with edema that in the opinion of the investigator requires higher compression than the 18-25mmHg provided by the compression socks
- •Patients who are currently wearing compression hose. (Patients who have been prescribed compression hose but have not worn compression stockings for the past 6 months can be included in the study)
- •Patients unable to walk one hundred feet.
研究组 & 干预措施
Mild Compression Diabetic Sock
Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
干预措施: mild compression diabetic sock (Device)
Standard Diabetic Sock
A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
干预措施: Standard diabetic sock (Device)
结局指标
主要结局
Foot Edema
时间窗: change from baseline after 4 weeks of sock usage
The circumference of the foot was measured by a tape measure.
Microcirculation for Lateral Calf
时间窗: change from baseline after 4 weeks of sock usage
microcirculation as measured by skin perfusion pressure
Microcirculation for Dorsum of Foot
时间窗: change from baseline after 4 weeks of sock usage
microcirculation as measured by skin perfusion pressure
Microcirculation for Medial Calf
时间窗: change from baseline after 4 weeks of sock usage
microcirculation as measured by skin perfusion pressure
Calf Edema
时间窗: change from baseline after 4 weeks of sock usage
The circumference of calf was measured by a tape measure.
Cutaneous Water Content
时间窗: change from baseline after 4 weeks of sock usage
Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.
Ankle Edema
时间窗: change from baseline after 4 weeks of sock usage
The circumference of ankle was measured by a tape measure.
Toe Brachial Index
时间窗: change from baseline after 4 weeks of sock usage
ratio of systolic blood pressure of toe relative to systolic blood pressure of arm
Ankle Brachial Index
时间窗: change from baseline after 4 weeks of sock usage
ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm
次要结局
- Physical Activity Level(baseline and after four weeks of wearing the socks)
研究者
Dr. Stephanie Wu, DPM, MS
Director of Center for Lower Extremity Ambulatory Research
Rosalind Franklin University of Medicine and Science