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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
Mahmoud Awad Ramadan Elkholy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 22, 2020
    Last Updated
    December 27, 2020
    Sponsor
    Mahmoud Awad Ramadan Elkholy
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    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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