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Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer

Primary Purpose

Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
insulin iontophoresis
topical insulin
conventional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients had chronic wound at foot
  • The patients ages were ranged from 40 to 70 years
  • The subjects were chosen from both sexes
  • All patients were diabetic patients

Exclusion Criteria:

  • uncontrolled wound bleeding
  • severe malnutrition
  • severeinfection
  • Immunodeficiency
  • age>70 years
  • renal failure
  • liver dysfunction
  • ischaemic limbs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    insulin iontophoresis

    topical insulin

    conventional treatment

    Arm Description

    the patients will receive insulin iontophoresis for thirty weeks

    the patients will receive topical insulin for thirty weeks

    the patients will receive standard dressing and normal saline twice daily for thirty weeks

    Outcomes

    Primary Outcome Measures

    life disability
    disability of life will be assessed by the quality of life questionnaire; The Questionnaire included 12 main questions, addressing seven specific areas of functional health status (physical functioning, role limitations due to physical health, role limitations due to emotional problems, wound status improvement, social functioning, pain, and general health). All questions were scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores were compiled as a percentage of the total points' possible (step 1 chart). The scores from the questions that address a specific area of functional health status were then averaged together, for a final score within each of the dimensions measured (step 2 chart). All seven categories were scored in the same way at the beginning and at the end of the course of care to track the progress of them.
    healing rate
    The major goal of this study was to achieve complete wound closure. The main area - final wound area (in mm2/healing time) in days was used to determine the wound healing rate, which was reported as mm2/day

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2022
    Last Updated
    July 1, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05444842
    Brief Title
    Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer
    Official Title
    Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer. Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 5, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    November 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study will be conducted to investigate the effect of Insulin iontophoresis mixed with oleic acid versus topical insulin in patients with chronic diabetic foot ulcer
    Detailed Description
    Despite insulin treatment and a meticulously controlled diet, approximately 15% of all patients with diabetes will, at some time, have non-healing wounds and this is the leading cause of lower extremity amputation. Wound healing involves cell adhesion, migration, proliferation, differentiation, and apoptosis at cellular and molecular levels. Abnormalities of distinct factors of wound healing contribute to defective wound healing in diabetes ulcers, including decreased growth factor production, angiogenic response, macrophage function, collagen accumulation, epidermal barrier. Insulin has great effect on ulcers healing and tissue regeneration but there is a catch that insulin is a large polymer that have difficulty crossing skin barrier but with using penetration enhancers like oleic acid combined with iontophoresis helps insulin to get through skin especially that affect locally on wound not systematic. Insulin help in restoring the function and structure of the vasculature and improving angiogenesis, reduces the local wound blood glucose concentration, thus reducing the damage resulting from the accumulation of high levels of glucose metabolic intermediates, insulin is the inhibitor of three major proinflammatory transcription factors: Nuclear factor-κB, activator protein-1 and early growth response-1 (EGR-1). insulin relieves the inflammatory response and prevents an excessive inflammatory reaction. Furthermore, insulin inhibits the degradation of immune cell proteins, thus enhancing immune activity. 45 patients with diabetic feet will be assigned randomly into 3 equal group; group A will receive insulin iontophoresis for 13 sessions, group B will receive topical insulin and group C will receive saline dressing for 13 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    insulin iontophoresis and topical insulin
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    random generator
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    insulin iontophoresis
    Arm Type
    Experimental
    Arm Description
    the patients will receive insulin iontophoresis for thirty weeks
    Arm Title
    topical insulin
    Arm Type
    Experimental
    Arm Description
    the patients will receive topical insulin for thirty weeks
    Arm Title
    conventional treatment
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive standard dressing and normal saline twice daily for thirty weeks
    Intervention Type
    Other
    Intervention Name(s)
    insulin iontophoresis
    Intervention Description
    All wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent). after cleaning the wound the insulin ions and oleic acid will be injected into the electrode of iontophoresis device (Phoresor_ IIAuto, ModelPM850, IOMED) then The device was set to the required dose of 40 mA-min, and the current intensity was gradually increased based on the subject's tolerance (ranging from 1 to 4 mA). The device computed the required time for the selected dose automatically.
    Intervention Type
    Other
    Intervention Name(s)
    topical insulin
    Intervention Description
    All wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent) after cleaning the wound For each 10cm2 of the wound, patients will get ten units (0.1 mL) of insulin crystal in solution with 1mL saline (0.9 percent). An insulin syringe needle was used to spray the solution twice daily on the wound area.
    Intervention Type
    Other
    Intervention Name(s)
    conventional treatment
    Intervention Description
    All wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent) after cleaning the wound For each 10cm2 of wound 1mL 0.9 percent saline was given.
    Primary Outcome Measure Information:
    Title
    life disability
    Description
    disability of life will be assessed by the quality of life questionnaire; The Questionnaire included 12 main questions, addressing seven specific areas of functional health status (physical functioning, role limitations due to physical health, role limitations due to emotional problems, wound status improvement, social functioning, pain, and general health). All questions were scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores were compiled as a percentage of the total points' possible (step 1 chart). The scores from the questions that address a specific area of functional health status were then averaged together, for a final score within each of the dimensions measured (step 2 chart). All seven categories were scored in the same way at the beginning and at the end of the course of care to track the progress of them.
    Time Frame
    up to thirty weeks
    Title
    healing rate
    Description
    The major goal of this study was to achieve complete wound closure. The main area - final wound area (in mm2/healing time) in days was used to determine the wound healing rate, which was reported as mm2/day
    Time Frame
    up to thirty weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients had chronic wound at foot The patients ages were ranged from 40 to 70 years The subjects were chosen from both sexes All patients were diabetic patients Exclusion Criteria: uncontrolled wound bleeding severe malnutrition severeinfection Immunodeficiency age>70 years renal failure liver dysfunction ischaemic limbs
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    al shaymaa sh abd el azeim, lecturer
    Phone
    01033771553
    Email
    alshaymaa.shaaban@pt.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    al shaymaa sh abd el azeim, lecturer
    Phone
    01033771553
    Email
    alshaymaa.ahaaban@pt.cu.edu.eg

    12. IPD Sharing Statement

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    Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer

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