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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06708975
Enrollment
40
Registered
2024-11-29
Start date
2024-12-31
Completion date
2025-02-28
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes mellites, Insulin Phonophoresis

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

Interventions

OTHERInsulin 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

OTHERHyperpolarized 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.

Sponsors

MTI University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

Contacts

Primary Contactamira saad Mohamed, Master degree
amira.saad.mm@gmail.com02-01092128481

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026