N/A
N=68
LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Trophic Ulcers · Chronic Venous Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT03104985 ↗Enrolled (actual)
68
Serious AEs
—
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Trophic Ulcer Healing — 11; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LASMIK (Device); Conventional therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Research Center Matrix
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Trophic Ulcer Healing |
11; 28 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03104985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.