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

Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer. Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: insulin iontophoresis; Other: topical insulin; Other: conventional treatment

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

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: insulin iontophoresis; the patients will receive insulin iontophoresis for thirty weeks	Other: insulin iontophoresis; 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.
EXPERIMENTAL: topical insulin; the patients will receive topical insulin for thirty weeks	Other: topical insulin; 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.
ACTIVE_COMPARATOR: conventional treatment; the patients will receive standard dressing and normal saline twice daily for thirty weeks	Other: conventional treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 5, 2022
• Primary Completion (ANTICIPATED): November 30, 2022
• Study Completion (ANTICIPATED): November 30, 2022

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (ACTUAL): July 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: p.t.REC/012/003670

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No