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临床试验/NCT02085317
NCT02085317已完成不适用

Observation of Microcirculation Impairment in Patients With Lepromatous Leprosy Using Orthogonal Polarization Spectral (OPS) Imaging and Laser Doppler Iontophoresis

Curt Treu0 个研究点目标入组 20 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
Laser-Doppler flowmetry

研究概览

简要总结

In this study the investigators have aimed to evaluate morphology and reactivity of cutaneous microcirculation in patients with lepromatous leprosy. Ten patients, without any other comorbidity were compared to ten controls without leprosy or any other comorbidity, using the Cytoscan® [orthogonal polarization spectral (OPS) imaging], Fourier analysis of laser Doppler signal to evaluate vasomotion (rhythmic spontaneous oscillation of arteriolar diameter) and laser Doppler flowmetry associated to iontophoresis of vasoactive substances (acetylcholine and sodium nitroprusside).

详细描述

Evaluation with OPS:

After acclimatization, the microcirculation of patients and controls was assessed by OPS in three different points, according to criteria recommended by De Backer(De Backer et al., 2007). Images were recorded for 10 seconds at each point and evaluated afterwards using Cap-Image v7.2software.

Evaluation with laser-Doppler flowmetry (LDF):

Skin blood perfusion was measured in conventional perfusion units (PU) by means of a LDF apparatus (Periflux PF4, Perimed, Stockholm, Sweden), equipped with a non-heated probe (PF408), fixed to the medial surface of the right forearm. Laser characteristics were: 780 nm wavelength, 10-19 kHz bandwidth, 0.1 s time constant and 32 Hz sampling frequency. Skin blood perfusion was expressed in conventional perfusion units (PU: 1 PU=10 mV) and LD signal was recorded continuously by an interfaced computer (Sony VaioVGN-CR160A) equipped with Perisoft dedicated software. Exams were performed in two steps:

First, to register vasomotion, a probe (Probe 481-1: Single Iontophoresis Probe - Perimed, Stockholm, Sweden) was placed, after the skin was cleaned with a wipe of 70° alcohol and left to air dry, in the dorsal face of the distal phalanx of the 2nd finger. The probes were positioned at least 10 cm apart, avoiding superficial veins and broken skin areas. This probe may be used for both vasomotion and iontophoresis. Basal blood perfusion was continuously recorded during 20 min. Skin temperature was continuously measured.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • male patients with only lepromatous leprosy in treatment
  • age between 20 and 60
  • body mass index (BMI) between 18 and 35 kg/m2
  • ability to follow given directions and to attend assessments and
  • Fitzpatrick's Phototype I-IV

排除标准

  • arterial hypertension
  • diabetes mellitus
  • BMI greater than 35 kg/m2
  • collagenosis
  • past or present history of smoking
  • age under 20 and over 60 years.

研究组 & 干预措施

Lepromatous Patients

Other

Composed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis

干预措施: acetylcholine Iontophoresis (Drug)

Lepromatous Patients

Other

Composed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis

干预措施: sodium nitroprusside Iontophoresis (Drug)

Healthy Patients

Other

Composed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis

干预措施: acetylcholine Iontophoresis (Drug)

Healthy Patients

Other

Composed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis

干预措施: sodium nitroprusside Iontophoresis (Drug)

结局指标

主要结局

Laser-Doppler flowmetry

时间窗: 0 - 20 min.

perfusion units (PU: 1 PU=10 mV)

次要结局

  • Cytoscan(0 - 5min)

研究者

发起方
Curt Treu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Curt Treu

Prof. Curt Treu

Rio de Janeiro State University

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