LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104985
• Other study ID #: LLLT-trophic-ulcers-Tula
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: Research Center Matrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• over 18 years of age,

• CVI Stage 6 (S6) in compliance with ????

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Leg Ulcer
• Trophic Ulcers
• Ulcer
• Venous Insufficiency

Intervention

Device:
• LASMIK
the physiotherapeutic device LASMIK (Registration Certificate in Russia ? RZN 2015/2687 dated 25.05.2015).

Other:
• Conventional therapy
An elastic compression of lower extremities, Pharmacotherapy, Topical treatment

Locations

Country	Name	City	State
Russian Federation	Tula Municipal Clinical Hospital ?2	Tula

Sponsors (1)

Lead Sponsor	Collaborator
Research Center Matrix

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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