Trophic UlcersNCT03104985
LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
A study testing LASMIK and Conventional therapy in people with Trophic Ulcers and Chronic Venous Insufficiency, run by Research Center Matrix at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Trophic Ulcers, Chronic Venous Insufficiency
- What is being tested?
- LASMIK and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteRussia
- Study dates
- May 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age,
- CVI Stage 6 (S6) in compliance with СЕАР
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Trophic Ulcers, Chronic Venous Insufficiency
- Being tested
- LASMIK, Conventional therapy
- Keywords
- Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASMIKDevice
the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).
Conventional therapyOther
- An elastic compression of lower extremities,
- Pharmacotherapy,
- Topical treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | 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). Receives: Other: Conventional therapy |
| Conventional therapy and combined LLLT | Experimental | 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:
1. - 365-405nm, power 1-2mW, exposure 2 min;
2. - 520-525nm, 1-2mW, 5 min;
3. - 365-405nm, 1-2mW, 2 min;
4. - 520-525nm, 1-2mW, 5 min;
5. - 365-405nm, 1-2mW, 2 min;
6. - 520-525nm, 1-2mW, 5 min;
7. - 365-405nm, 1-2mW, 2 min;
8. - 520-525nm, 1-2mW, 5 min;
9. - 365-405nm, 1-2mW, 2 min;
10. - 520-525nm, 1-2mW, 5 min;
11. - 365-405nm, 1-2mW, 2 min;
12. - 520-525nm, 1-2mW, 5 min Receives: Device: LASMIK; Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trophic UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center Matrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey Moskvin, Principal investigator, State Scientific Center of Laser Medicine, Russia, Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104985
- Sponsor's protocol ID
- LLLT-trophic-ulcers-Tula
- Status last verified
- Feb 2018
- First submitted
- 21 Mar 2017
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT03104985
- Acronym / sponsor ID
- LLLT-trophic-ulcers-Tula
- Conditions
- Trophic Ulcers, Chronic Venous Insufficiency
- Keywords
- Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Research Center MatrixUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 1 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Other: Conventional therapyConventional 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 | Experimental | Device: LASMIK, Other: Conventional therapyConventional 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: 1. - 365-405nm, power 1-2mW, exposure 2 min; 2. - 520-525nm, 1-2mW, 5 min; 3. - 365-405nm, 1-2mW, 2 min; 4. - 520-525nm, 1-2mW, 5 min; 5. - 365-405nm, 1-2mW, 2 min; 6. - 520-525nm, 1-2mW, 5 min; 7. - 365-405nm, 1-2mW, 2 min; 8. - 520-525nm, 1-2mW, 5 min; 9. - 365-405nm, 1-2mW, 2 min; 10. - 520-525nm, 1-2mW, 5 min; 11. - 365-405nm, 1-2mW, 2 min; 12. - 520-525nm, 1-2mW, 5 min |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age,
- CVI Stage 6 (S6) in compliance with СЕАР
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASMIKthe physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015). | Device | Conventional therapy and combined LLLT |
| Conventional therapy* An elastic compression of lower extremities, * Pharmacotherapy, * Topical treatment | Other | Conventional therapy and combined LLLT, Conventional treatment |
Primary outcome
Number of Participants With Trophic Ulcer Healing
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Educational website with publications, scientific articles, training manuals, guidelines, books on LLLT.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Moskvin principal investigator
State Scientific Center of Laser Medicine, Russia, Moscow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASMIK and Conventional therapy in people with Trophic Ulcers and Chronic Venous Insufficiency, run by Research Center Matrix at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Trophic Ulcer Healing (time frame: 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.