Helium Neon Laser Versus Gallium Arsenide Laser
Primary Purpose
Venous Leg Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
Eligibility Criteria
Inclusion Criteria:
- All patients approximately the same age (50-60).
- All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
- All patients with conscious.
Exclusion Criteria:
- All patients had no diabetes or blood problems.
- any immunity disorder affect wound heaing.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HELIUM NEON LASER plus regular ulcer care
GALLIUM ARSENIDE plus regular ulcer care
regular ulcer care
Arm Description
laser scanning the wound with 9.6 jole/cm2 then regular dressing
laser scanning the wound with 9.6 jole/cm2 then regular dressing
dressing for the ulcer
Outcomes
Primary Outcome Measures
wound surface area
measuring the ulcer surface area by smart phone application
number of bacteria in wound
measuring number of bacteria by colony count
Secondary Outcome Measures
Full Information
NCT ID
NCT04689620
First Posted
December 22, 2020
Last Updated
December 27, 2020
Sponsor
Mahmoud Awad Ramadan Elkholy
1. Study Identification
Unique Protocol Identification Number
NCT04689620
Brief Title
Helium Neon Laser Versus Gallium Arsenide Laser
Official Title
Helium Neon Laser Versus Gallium Arsenide Laser In Healing Of Venous Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2020 (Anticipated)
Primary Completion Date
December 28, 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Awad Ramadan Elkholy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There will be different effects for different laser wavelengths in treatment of venous ulcer.
Detailed Description
The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.
Poor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.
So, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HELIUM NEON LASER plus regular ulcer care
Arm Type
Experimental
Arm Description
laser scanning the wound with 9.6 jole/cm2 then regular dressing
Arm Title
GALLIUM ARSENIDE plus regular ulcer care
Arm Type
Experimental
Arm Description
laser scanning the wound with 9.6 jole/cm2 then regular dressing
Arm Title
regular ulcer care
Arm Type
Active Comparator
Arm Description
dressing for the ulcer
Intervention Type
Device
Intervention Name(s)
laser
Intervention Description
treating the venous ulcer with laser
Primary Outcome Measure Information:
Title
wound surface area
Description
measuring the ulcer surface area by smart phone application
Time Frame
two months
Title
number of bacteria in wound
Description
measuring number of bacteria by colony count
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients approximately the same age (50-60).
All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
All patients with conscious.
Exclusion Criteria:
All patients had no diabetes or blood problems.
any immunity disorder affect wound heaing.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
statistical analysis plan
Learn more about this trial
Helium Neon Laser Versus Gallium Arsenide Laser
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