Trial Outcomes & Findings for LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency (NCT NCT03104985)
NCT ID: NCT03104985
Last Updated: 2018-11-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
6 months follow up
Results posted on
2018-11-01
Participant Flow
Participant milestones
| Measure |
Conventional Treatment
* 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: - An elastic compression of lower extremities,
* Pharmacotherapy,
* Topical treatment
|
Conventional Therapy and Combined LLLT
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
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Conventional Treatment
n=34 Participants
Conventional treatment only.
|
Conventional Therapy and Combined LLLT
n=34 Participants
Conventional therapy and combined LLLT (LASMIK device)
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 years
n=34 Participants
|
57.5 years
n=34 Participants
|
57.2 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=34 Participants
|
25 Participants
n=34 Participants
|
50 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=34 Participants
|
9 Participants
n=34 Participants
|
18 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
34 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
68 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 6 months follow upNumber 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.
Outcome measures
| Measure |
Conventional Treatment
n=34 Participants
Conventional treatment only.
|
Conventional Therapy and Combined LLLT
n=34 Participants
Conventional therapy and combined LLLT (LASMIK device).
|
|---|---|---|
|
Number of Participants With Trophic Ulcer Healing
|
11 Participants
|
28 Participants
|
Adverse Events
Conventional Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Therapy and Combined LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sergey Moskvin
State Scientific Center of Laser Medicine, Russia, Moscow
Phone: +7-905-770-1860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place