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
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
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
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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