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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin therapy phonophoresis

Other

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

Hyperpolarized light therapy and Standard wound cleaning and dressing.

Other

Hyperpolarized light therapy safely accelerates wound healing by stimulating blood circulation, reducing inflammation and relieving muscle spasms.

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.

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

amira saad Mohamed, Master degree

CONTACT

[email protected]

02-01092128481

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

Effect of Transdermal Insulin Therapy by Ultrasonographic in Wound Healing of Chronic Diabetic Patients

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 29, 2024
Registry last updated: Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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