Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients

N/ANot Yet RecruitingNCT06708975

MTI University40 enrolled

Overview

The main aim of the study is to determine the effect of transdermal application of insulin therapy by phonophoresis in wound healing in diabetic patients the main question of the study: is insulin phonophoresis is effective in accelerating healing in patients with diabetes mellites? 40 patients will be randomly assigned to two groups group A will receive insulin phonophoresis plus hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks. Group B will receive hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.

DIMST scale ( as an acronym from the initial domains of depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining) will be used for assessment. MANOVA will be used for statistical analysis between group comparison

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Insulin therapy phonophoresis is the use of ultrasound to deliver drugs through patients skin, Insulin therapy will be used to determine its effect on wound healing in patients with chronic diabetes mellites because in addition to its systemic impact, numerous reports suggest that applying insulin topically causes localized effects. Many trials and case reports have been released reporting positive effects of topical insulin for many diseases such as dermatological compromises, ophthalmological diseases and others

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients. Exclusion Criteria: patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Outcomes

Primary Outcomes

DMIST scale which is a valid and reliable scale for measuring depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining.

Zero will be the minimum score and 98 was the maximum, with a greater number denoting a more severe injury and a zero signaling full recovery

Time frame: before first session and at the end of the treatment program (four weeks)