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Microcirculatory Impairment in Patients With Leprosy

Primary Purpose

Lepromatous Leprosy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acetylcholine Iontophoresis
sodium nitroprusside Iontophoresis
Sponsored by
Curt Treu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lepromatous Leprosy focused on measuring Microcirculation, Leprosy, Nervous system, Orthogonal polarization spectral (OPS) imaging, Laser Doppler flowmetry, Iontophoresis.

Eligibility Criteria

20 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Lepromatous Patients

    Healthy Patients

    Arm Description

    Composed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis

    Composed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis

    Outcomes

    Primary Outcome Measures

    Laser-Doppler flowmetry
    perfusion units (PU: 1 PU=10 mV)

    Secondary Outcome Measures

    Cytoscan
    Using the Cystoscan, we have evaluated functional capillary density, diameter of the dermal papilla, capillary diameter, capillary handle diameter and capillary morphology

    Full Information

    First Posted
    March 2, 2014
    Last Updated
    March 10, 2014
    Sponsor
    Curt Treu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02085317
    Brief Title
    Microcirculatory Impairment in Patients With Leprosy
    Official Title
    Observation of Microcirculation Impairment in Patients With Lepromatous Leprosy Using Orthogonal Polarization Spectral (OPS) Imaging and Laser Doppler Iontophoresis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Curt Treu

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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. To avoid residual effects of previously used drugs, the probe position for combined iontophoresis and LDF recordings were placed in untreated fingers [2nd for acetylcholine (Ach) and 3nd for sodium nitroprusside (SNP)] after each measurement . Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc. After Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lepromatous Leprosy
    Keywords
    Microcirculation, Leprosy, Nervous system, Orthogonal polarization spectral (OPS) imaging, Laser Doppler flowmetry, Iontophoresis.

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lepromatous Patients
    Arm Type
    Other
    Arm Description
    Composed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis
    Arm Title
    Healthy Patients
    Arm Type
    Other
    Arm Description
    Composed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis
    Intervention Type
    Drug
    Intervention Name(s)
    acetylcholine Iontophoresis
    Intervention Description
    Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc.
    Intervention Type
    Drug
    Intervention Name(s)
    sodium nitroprusside Iontophoresis
    Intervention Description
    After Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one.
    Primary Outcome Measure Information:
    Title
    Laser-Doppler flowmetry
    Description
    perfusion units (PU: 1 PU=10 mV)
    Time Frame
    0 - 20 min.
    Secondary Outcome Measure Information:
    Title
    Cytoscan
    Description
    Using the Cystoscan, we have evaluated functional capillary density, diameter of the dermal papilla, capillary diameter, capillary handle diameter and capillary morphology
    Time Frame
    0 - 5min

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: females arterial hypertension diabetes mellitus BMI greater than 35 kg/m2 collagenosis past or present history of smoking age under 20 and over 60 years.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    curt treu, PhD
    Organizational Affiliation
    Rio de Janeiro State University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Eliete Bouskela, PhD
    Organizational Affiliation
    Rio de Janeiro State University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Microcirculatory Impairment in Patients With Leprosy

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