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LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Primary Purpose

Trophic Ulcers, Chronic Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
LASMIK
Conventional therapy
Sponsored by
Research Center Matrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trophic Ulcers focused on measuring Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years of age,
  • CVI Stage 6 (S6) in compliance with СЕАР

Exclusion Criteria:

  • hemorrhagic syndrome,
  • neoplastic syndrome,
  • hyperthermic syndrome (fever, patient body temperature over 38°C),
  • syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multiple organ failure (general severe illness),
  • cachexic syndrome (severe general exhaustion),
  • epileptic syndrome,
  • hysterical syndrome,
  • convulsive syndrome

Sites / Locations

  • Tula Municipal Clinical Hospital №2

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional treatment

Conventional therapy and combined LLLT

Arm Description

Conventional treatment only. An elastic compression of lower extremities: elastic bandages or compression hosiery of class 2 Pharmacotherapy: Anavenol, Aescusan, Glyvenol; drugs of the Benzopyrone group, including Troxevasin and Venoruton. Trental, Aspirin and Ticlid (Ticlopidine). Nonsteroidal anti-inflammatory drugs (Nimesil, OKI), various ointments containing Heparin, corticosteroids, as well as nonsteroidal anti-inflammatory drugs. Antibiotic therapy. Topical treatment: in the presence of purulent discharge (phase I of the wound healing process) - bandaging with antiseptic solutions (1% Iodopiron solution, 0.1% Chlorhexidine solution) and hydrophilic ointments (Levosin, Levomecol). In phases II and III - after ulcer cleansing the preparations based on Hyaluronic acid (Curiozin).

Conventional therapy and combined LLLT (LASMIK device) was performed. External exposure was conducted on the 1-4 affected area during one session for 2 minutes per zone in pulsed mode, light pulse duration - 100-130ns, wavelength - 635nm, by a matrix emitter consisting of eight laser diodes with a surface area of 8cm2, at a distance of up to 7cm, with pulsed power of 40W. ILBI was conducted in continuous mode with wavelength between 365-405nm (UV-spectrum) and 520-525nm (green spectrum) alternately, during 12 daily treatment sessions according to the scheme: - 365-405nm, power 1-2mW, exposure 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min

Outcomes

Primary Outcome Measures

Number of Participants With Trophic Ulcer Healing
Number of participants with ulcer epithelialization was counted in both groups. Trophic ulcer healing in 6 months occurred in larger number of participants of conventional therapy and combined LLLT group.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2017
Last Updated
February 22, 2018
Sponsor
Research Center Matrix
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1. Study Identification

Unique Protocol Identification Number
NCT03104985
Brief Title
LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Official Title
New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Center Matrix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of C6 class, and a new combined low level laser therapy (LLLT) by LASMIK device. The results of outpatient examination and treatment of patients with venous trophic ulcers, observed in the City Polyclinic of "Tula Municipal Clinical Hospital №2" were analyzed.
Detailed Description
During a longitudinal study, a group of patients was followed up in the period of complete or partial recovery. International classification of lower extremity chronic venous disorders СЕАР was used as a clinical classification of chronic venous insufficiency (CVI). Depending on the applied treatment method, patients were divided into 2 groups: (n=34) Conventional treatment (n=34) Conventional treatment + combined LLLT, including external exposure with 635nm wavelength + intravenous laser blood illumination (ILBI) with 365-405nm (UV-spectrum) and 520-525nm (green spectrum) wavelength alternately, according to the special scheme

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trophic Ulcers, Chronic Venous Insufficiency
Keywords
Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Conventional treatment only. An elastic compression of lower extremities: elastic bandages or compression hosiery of class 2 Pharmacotherapy: Anavenol, Aescusan, Glyvenol; drugs of the Benzopyrone group, including Troxevasin and Venoruton. Trental, Aspirin and Ticlid (Ticlopidine). Nonsteroidal anti-inflammatory drugs (Nimesil, OKI), various ointments containing Heparin, corticosteroids, as well as nonsteroidal anti-inflammatory drugs. Antibiotic therapy. Topical treatment: in the presence of purulent discharge (phase I of the wound healing process) - bandaging with antiseptic solutions (1% Iodopiron solution, 0.1% Chlorhexidine solution) and hydrophilic ointments (Levosin, Levomecol). In phases II and III - after ulcer cleansing the preparations based on Hyaluronic acid (Curiozin).
Arm Title
Conventional therapy and combined LLLT
Arm Type
Experimental
Arm Description
Conventional therapy and combined LLLT (LASMIK device) was performed. External exposure was conducted on the 1-4 affected area during one session for 2 minutes per zone in pulsed mode, light pulse duration - 100-130ns, wavelength - 635nm, by a matrix emitter consisting of eight laser diodes with a surface area of 8cm2, at a distance of up to 7cm, with pulsed power of 40W. ILBI was conducted in continuous mode with wavelength between 365-405nm (UV-spectrum) and 520-525nm (green spectrum) alternately, during 12 daily treatment sessions according to the scheme: - 365-405nm, power 1-2mW, exposure 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min
Intervention Type
Device
Intervention Name(s)
LASMIK
Intervention Description
the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
An elastic compression of lower extremities, Pharmacotherapy, Topical treatment
Primary Outcome Measure Information:
Title
Number of Participants With Trophic Ulcer Healing
Description
Number of participants with ulcer epithelialization was counted in both groups. Trophic ulcer healing in 6 months occurred in larger number of participants of conventional therapy and combined LLLT group.
Time Frame
6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years of age, CVI Stage 6 (S6) in compliance with СЕАР Exclusion Criteria: hemorrhagic syndrome, neoplastic syndrome, hyperthermic syndrome (fever, patient body temperature over 38°C), syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multiple organ failure (general severe illness), cachexic syndrome (severe general exhaustion), epileptic syndrome, hysterical syndrome, convulsive syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Moskvin
Organizational Affiliation
State Scientific Center of Laser Medicine, Russia, Moscow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tula Municipal Clinical Hospital №2
City
Tula
ZIP/Postal Code
300002
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.lazmik.ru
Description
Educational website with publications, scientific articles, training manuals, guidelines, books on LLLT.

Learn more about this trial

LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

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