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
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
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
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
Learn more about this trial
Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer
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