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Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing

Primary Purpose

Wound Healing Delayed

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microcurrent therapy
Low Level Laser Therapy
Medical therapy
Sponsored by
Nehad Ahmed Youness Abo-zaid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing Delayed

Eligibility Criteria

10 Years - 50 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patient recently undergo appendectomy

Exclusion Criteria:

  • patient with neurological disorders
  • patient with metabolic disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    medical therapy group

    medical therapy and Microcurrent group

    medical therapy and Low-Level Laser Therapy group

    Arm Description

    formed of 20 patients to whom ordinary medical therapy as the pervious groups and placebo shame laser had been applied.

    formed of 20 patients to whom the microcurrent therapy had been applied with ordinary medical therapy.

    formed of 20 patients to whom the Low Level Laser Therapy had been applied with ordinary medical therapy.

    Outcomes

    Primary Outcome Measures

    levels of matrix metalloproteinases
    analyze by Enzyme-linked immunosorbent assay

    Secondary Outcome Measures

    levels of matrix metalloproteinases
    analyze by Enzyme-linked immunosorbent assay
    the tissue inhibitors of metalloproteinases
    analyze by Enzyme-linked immunosorbent assay
    the tissue inhibitors of metalloproteinases
    analyze by Enzyme-linked immunosorbent assay

    Full Information

    First Posted
    March 23, 2022
    Last Updated
    April 6, 2022
    Sponsor
    Nehad Ahmed Youness Abo-zaid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05326022
    Brief Title
    Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing
    Official Title
    Microcurrent Therapy Versus Low-Level Laser Therapy on Post-surgical Wound Healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 28, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nehad Ahmed Youness Abo-zaid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing
    Detailed Description
    The study designed to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Healing Delayed

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    medical therapy group
    Arm Type
    Experimental
    Arm Description
    formed of 20 patients to whom ordinary medical therapy as the pervious groups and placebo shame laser had been applied.
    Arm Title
    medical therapy and Microcurrent group
    Arm Type
    Experimental
    Arm Description
    formed of 20 patients to whom the microcurrent therapy had been applied with ordinary medical therapy.
    Arm Title
    medical therapy and Low-Level Laser Therapy group
    Arm Type
    Experimental
    Arm Description
    formed of 20 patients to whom the Low Level Laser Therapy had been applied with ordinary medical therapy.
    Intervention Type
    Device
    Intervention Name(s)
    Microcurrent therapy
    Intervention Description
    Microcurrent therapy
    Intervention Type
    Device
    Intervention Name(s)
    Low Level Laser Therapy
    Intervention Description
    Laser therapy
    Intervention Type
    Other
    Intervention Name(s)
    Medical therapy
    Intervention Description
    Medical therapy
    Primary Outcome Measure Information:
    Title
    levels of matrix metalloproteinases
    Description
    analyze by Enzyme-linked immunosorbent assay
    Time Frame
    assessed at day 3 post operative
    Secondary Outcome Measure Information:
    Title
    levels of matrix metalloproteinases
    Description
    analyze by Enzyme-linked immunosorbent assay
    Time Frame
    assessed at day 30 post operative
    Title
    the tissue inhibitors of metalloproteinases
    Description
    analyze by Enzyme-linked immunosorbent assay
    Time Frame
    assessed at day 3 post operative
    Title
    the tissue inhibitors of metalloproteinases
    Description
    analyze by Enzyme-linked immunosorbent assay
    Time Frame
    assessed at day 30 post operative

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient recently undergo appendectomy Exclusion Criteria: patient with neurological disorders patient with metabolic disorders
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nehad A. Abo-Zaid, PhD
    Phone
    +201223265216
    Email
    dr.nehadahmed@svu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed E. Ali, PhD
    Phone
    +201011212425
    Email
    m.essam@svu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nehad A. Abo-Zaid, PhD
    Organizational Affiliation
    South Valley University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27547189
    Citation
    Dickinson LE, Gerecht S. Engineered Biopolymeric Scaffolds for Chronic Wound Healing. Front Physiol. 2016 Aug 5;7:341. doi: 10.3389/fphys.2016.00341. eCollection 2016.
    Results Reference
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    Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing

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