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

MTI University

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Other: Insulin therapy phonophoresis; Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.

Study type: Interventional

Funder types: Other

Identifiers

NCT06708975

P.T.REC/012/005342

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Group A

Experimental group

Description:

subjects will receive Phonophoresis Insulin Therapy, hyperpolarized light therapy and Standard wound cleaning and dressing.

Treatment:

Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.

Other: Insulin therapy phonophoresis

Group B

Sham Comparator group

Description:

subjects will receive hyperpolarized light therapy and Standard wound cleaning and dressing

Treatment:

Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.