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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Other: insulin iontophoresis; Other: conventional treatment; Other: topical insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05444842

p.t.REC/012/003670

Details and patient eligibility

About

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

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

insulin iontophoresis

Experimental group

Description:

the patients will receive insulin iontophoresis for thirty weeks

Treatment:

Other: insulin iontophoresis

topical insulin

Experimental group

Description:

the patients will receive topical insulin for thirty weeks

Treatment:

Other: topical insulin

conventional treatment

Active Comparator group

Description:

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

Treatment:

Other: conventional treatment