LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency; Trophic Ulcers
• Intervention / Treatment: Other: Conventional therapy; Device: LASMIK

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:

1. (n=34) Conventional treatment
2. (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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tula, Russian Federation, 300002
    • Tula Municipal Clinical Hospital №2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment; 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).	Other: Conventional therapy; An elastic compression of lower extremities,; Pharmacotherapy,; Topical treatment
Experimental: Conventional therapy and combined LLLT; 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	Other: Conventional therapy; An elastic compression of lower extremities,; Pharmacotherapy,; Topical treatment; Device: LASMIK; the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months follow up

Collaborators and Investigators

• Sponsor: Research Center Matrix
• Investigators: Principal Investigator: Sergey Moskvin, State Scientific Center of Laser Medicine, Russia, Moscow

Publications and helpful links

Helpful Links

• Educational website with publications, scientific articles, training manuals, guidelines, books on LLLT.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer; Venous Insufficiency
• Other Study ID Numbers: LLLT-trophic-ulcers-Tula

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No