Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insulin therapy phonophoresis, Hyperpolarized light therapy and Standard wound cleaning and dressing..
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Transdermal Insulin Therapy by Ultrasonographic in Wound Healing of Chronic Diabetic Patients
Overview
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
- Other 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 - 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.
Primary outcome measures
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06708975 · P.T.REC/012/005342