Chronic Venous Insufficiency, Trophic Ulcers
Conditions
Keywords
Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
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: 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
Interventions
DEVICELASMIK
the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).
OTHERConventional therapy
* An elastic compression of lower extremities, * Pharmacotherapy, * Topical treatment
Sponsors
Research Center Matrix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Trophic Ulcer Healing | 6 months follow up | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Treatment Conventional treatment only. | 34 |
| Conventional Therapy and Combined LLLT Conventional therapy and combined LLLT (LASMIK device) | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | Conventional Therapy and Combined LLLT | Total | Conventional Treatment |
|---|---|---|---|
| Age, Continuous | 57.5 years | 57.2 years | 56.9 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 months follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment | Number of Participants With Trophic Ulcer Healing | 11 Participants |
| Conventional Therapy and Combined LLLT | Number of Participants With Trophic Ulcer Healing | 28 Participants |