Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients
Effect of Transdermal Insulin Therapy by Ultrasonographic 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.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: amira saad Mohamed, Master degree
- Phone Number: 02-01092128481
- Email: amira.saad.mm@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
subjects will receive Phonophoresis Insulin Therapy, hyperpolarized light therapy and Standard wound cleaning and dressing.
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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 safely accelerates wound healing by stimulating blood circulation, reducing inflammation and relieving muscle spasms.
|
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Sham Comparator: Group B
subjects will receive 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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before first session and at the end of the treatment program (four weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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