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Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Primary Purpose

Wound Heal

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin
Sponsored by
Ministry of Health, Bahrain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with Texas 1 and 2 wound criteria

Exclusion Criteria: Texas 3 and 4 wound criteria

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Before starting the therapeutic procedure, all wounds will be fully washed with normal saline. Group A patients will receive 10 units (0.1 mL) of regular insulin (manufactured by novo nordisk) in solution with 1 cc of normal saline 0.9% for each 10 cm of wound. The solution will be sprayed on the wound surface with an insulin syringe needle, once daily. The patients in this arm will receive conventional therapy.

    Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin

    Outcomes

    Primary Outcome Measures

    Area of wound healing
    Rate of wound healing will be calculated as the difference between the primary and final wound area in mm as a function of healing time (in days) and reported as mm/day.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2020
    Last Updated
    May 17, 2020
    Sponsor
    Ministry of Health, Bahrain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04390815
    Brief Title
    Effect of Insulin on Wound Healing-A Randomized Controlled Trial
    Official Title
    Effect of Insulin on Wound Healing- A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Health, Bahrain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A randomized controlled trial examining the effect of insulin on wound healing in both diabetics and non diabetic patients in a local health center in Bahrain.
    Detailed Description
    This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics. The study will run in primary care setting in Bahrain. The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing. All adult patients with skin wounds attending primary health care center will be included in the study. Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Before starting the therapeutic procedure, all wounds will be fully washed with normal saline. Group A patients will receive 10 units (0.1 mL) of regular insulin (manufactured by novo nordisk) in solution with 1 cc of normal saline 0.9% for each 10 cm of wound. The solution will be sprayed on the wound surface with an insulin syringe needle, once daily. The patients in this arm will receive conventional therapy.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin
    Other Intervention Name(s)
    Regular Insulin
    Intervention Description
    Adding insulin to conventional wound treatment
    Primary Outcome Measure Information:
    Title
    Area of wound healing
    Description
    Rate of wound healing will be calculated as the difference between the primary and final wound area in mm as a function of healing time (in days) and reported as mm/day.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with Texas 1 and 2 wound criteria Exclusion Criteria: Texas 3 and 4 wound criteria -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all collected IPD will be shared
    IPD Sharing Time Frame
    4 months
    Citations:
    PubMed Identifier
    35667792
    Citation
    Xue Y, Reddy SK, Garza LA. Toward Understanding Wound Immunology for High-Fidelity Skin Regeneration. Cold Spring Harb Perspect Biol. 2022 Jul 1;14(7):a041241. doi: 10.1101/cshperspect.a041241.
    Results Reference
    derived

    Learn more about this trial

    Effect of Insulin on Wound Healing-A Randomized Controlled Trial

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