Assessment of the immediate effect of Buerger-Allen exercise on the skin perfusion levels using Laser Speckle Contrast Imaging in patients with Peripheral Artery Disease - A quasi experimental study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
研究概览
简要总结
Examination of lower extremities for physical abnormalities, ulcers, or skin discoloration will be done. The participant will undergo basic vascular examination, including pulse palpation (dorsalis pedis, posterior tibial).
Measurement of Ankle-Brachial Index (ABI):will be performed using two different techniques:
Manual ABI measurement (using standard Doppler method by Investigator as well as Vasosense ABI measurement (oscillometric, automate)
Perfusion imaging will be performed using Angiocam (Ayati Devices, India) at predefined anatomical regions of interest (ROIs) on the foot. Images will be captured and analysed over the dorsal foot, plantar foot, medial foot, and lateral foot regions to quantify perfusion changes. Buerger-Allen exercise is prescribed to the participant.as per the standard protocol.
Immediate post intervention assessments of the patient’s skin perfusion levels are taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Peripheral Artery Disease (PAD) of the lower limbs based on clinical assessment and objective vascular testing (e.g., ABI, Doppler, CTA/MRA/DSA) Scheduled for endovascular intervention (angioplasty ± stenting ± adjunctive procedures) for lower-limb PAD At least one accessible imaging site on the foot, ankle, or distal leg suitable for LSCI imaging (not fully covered by casts, heavy dressings, or external fixation) Able to lie supine and tolerate LSCI imaging immediately pre- and post-intervention Able and willing to provide written informed consent.
排除标准
- •Acute limb ischemia requiring emergency revascularization or thrombectomy where study imaging could delay life- or limb-saving treatment Hemodynamic instability or critical illness (e.g., on inotropic support, severe sepsis) precluding safe participation Extensive limb dressings, external fixation, or plaster casts that prevent adequate LSCI imaging of the distal limb Major tissue loss or active infection at planned imaging sites that could interfere with perfusion measurements Inability or unwillingness to comply with the imaging protocol or required follow-up assessments Concurrent participation in another interventional trial that, in the opinion of the investigator, could confound perfusion measurements.
研究者
Dr Srihari Sharma K N
Dayananda Sagar University