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

NCT ID: NCT06708975

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-02-28

Brief Summary

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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

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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

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Insulin therapy phonophoresis

Intervention Type 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.

Intervention Type OTHER

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

Group B

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

Group Type SHAM_COMPARATOR

Hyperpolarized light therapy and Standard wound cleaning and dressing.

Intervention Type OTHER

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

Interventions

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Insulin therapy phonophoresis

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

Intervention Type OTHER

Hyperpolarized light therapy and Standard wound cleaning and dressing.

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MTI University

OTHER

Sponsor Role lead

Responsible Party

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Radwa Fayek Hammam

Lecturer at Basic Science Department, Faculty of Physical Therapy Modern University for Technology and Information

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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amira saad Mohamed, Master degree

Role: CONTACT

02-01092128481

Related Links

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Other Identifiers

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P.T.REC/012/005342

Identifier Type: -

Identifier Source: org_study_id