Microcirculatory Impairment in Patients With Leprosy

March 10, 2014 updated by: Curt Treu

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lepromatous Patients
Composed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis
Drug: acetylcholine Iontophoresis
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.
Drug: sodium nitroprusside Iontophoresis
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.
Other: Healthy Patients
Composed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis
Drug: acetylcholine Iontophoresis
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.
Drug: sodium nitroprusside Iontophoresis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laser-Doppler flowmetry
Time Frame: 0 - 20 min.
perfusion units (PU: 1 PU=10 mV)
0 - 20 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytoscan
Time Frame: 0 - 5min
Using the Cystoscan, we have evaluated functional capillary density, diameter of the dermal papilla, capillary diameter, capillary handle diameter and capillary morphology
0 - 5min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curt Treu

Investigators

  • Principal Investigator: curt treu, PhD, Rio de Janeiro State University
  • Study Director: Eliete Bouskela, PhD, Rio de Janeiro State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 2, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biovasc-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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