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

Not Applicable
Not yet recruiting
Conditions
Diabetes Mellitus
Registration Number
NCT06708975
Lead Sponsor
MTI University
Brief Summary

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.

Detailed Description

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

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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.before first session and at the end of the treatment program (four weeks)

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

Secondary Outcome Measures
NameTimeMethod
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