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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05444842
• Other study ID #: p.t.REC/012/003670
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: al shaymaa sh abd el azeim, lecturer
• Phone: 01033771553
• Email: alshaymaa.shaaban[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Foot Ulcer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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