Comparison of Ankle Brachial Index among diabetic and non diabetic age matched individuals.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Ankle Brachial Index
研究概览
简要总结
Ankle brachial index (ABI) is widely used for determining the presence and severity of peripheral arterial disease (PAD) and current guidelines suggest it should be used to monitor possible progression in affected individual. Existing studies suggest the ABI is reliable in general population however, there is a lack of evidence for its association in people with diabetes. It is a comparative study which will require 30mins/per participant. Participants fulfilling inclusion and exclusion criteria will be enrolled, The ABI is a non-invasive method and is typically calculated as the ratio of the highest of the dorsalis pedis and posterior tibial artery systolic pressure to the highest of the left and right brachial systolic pressures using a minidop ES-100VX(Hadeco) hand held vascular doppler The cuff position will be ensured for it to be at the heart level. All BP will be measured once, with a minimum of 3 minutes between pressure measurements. For measuring brachial pressures place the ultrasound gel in the antecubital fossa over the patient’s brachial pulse. Place the transducer of the handheld Doppler on the gel, and position the transducer to maximize the intensity of the signal. Inflate the cuff to about 20 mmHg above the expected systolic blood pressure of the patient. The Doppler signal should disappear. Then slowly deflate the cuff, approximately 1 mmHg/sec. When the Doppler signal re-appears, the pressure of the cuff is equal to the brachial systolic pressure. Record the brachial systolic pressure. Similarly the Doppler signal of the dorsalis pedis is often been found slightly lateral to the midline of the dorsum of the foot and posterior tibial signal is detected posterior to the medial malleolus. Normal value for ABI assessment within the general population is considered to be 1.00–1.40, with values 0.91–0.99 classed as ‘borderline’, while those below 0.91 represent likely PAD.ABI of both groups of Asymptomatic type 2 Diabetic individuals between 40-60 of age with DM duration of more than 5 years and Non-diabetic individuals between 40- 60 of age including both the genders will be compared. Individuals with contraindication to brachial &/or ankle pressure measurement including history of DVT , lymphoedema of arm or legs ,history of mastectomy or current leg ulceration and inability to lie supine. Any other condition causing PAD other than diabetes like Buerger’s disease will be excluded. Total sample size is 46,with 23 in each group. Analysis of the data will be done using appropriate statistical test.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Group A :- Asymptomatic type 2 Diabetic individual between 40-60 years of age with DM duration of more than 5 years including both the gender.
- •Group B:- Non diabetic individuals between 40-60 years of age including both the gender.
排除标准
- •Contraindication to brachial &/or ankle pressure measurement including history of DVT , lymphoedema of arm or legs.
- •History of mastectomy or current leg ulceration and inability to lie supine.
- •Any other condition causing PAD other than diabetes like Buerger’s disease.
结局指标
主要结局
Ankle Brachial Index
时间窗: Once(Baseline )
次要结局
- Skin temperature(Once(Baseline))
