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

NCT05444842 | Unknown

• 1 other identifier: p.t.REC/012/003670
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

  up to thirty weeks

• 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

  up to thirty weeks

Study Arms (3)

insulin iontophoresis

EXPERIMENTAL

the patients will receive insulin iontophoresis for thirty weeks

Other: insulin iontophoresis

topical insulin

EXPERIMENTAL

the patients will receive topical insulin for thirty weeks

Other: topical insulin

conventional treatment

ACTIVE COMPARATOR

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

Other: conventional treatment

Interventions

insulin iontophoresis OTHER

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.

insulin iontophoresis

topical insulin OTHER

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.

topical insulin

conventional treatment OTHER

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.

conventional treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

al shaymaa sh abd el azeim, lecturer

CONTACT

01033771553; alshaymaa.shaaban@pt.cu.edu.eg

al shaymaa sh abd el azeim, lecturer

CONTACT

01033771553; alshaymaa.ahaaban@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: insulin iontophoresis and topical insulin

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 6, 2022
• Study Start: July 5, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07