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

NCT06708975 | Not Yet Recruiting DMC

• 1 other identifier: P.T.REC/012/005342
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Keywords

diabetes mellites, Insulin Phonophoresis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  before first session and at the end of the treatment program (four weeks)

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Insulin therapy phonophoresis; Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.

Group B

SHAM COMPARATOR

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

Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.

Interventions

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

Group A

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.

Group A; Group B

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

You may not qualify if:

• patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Sponsors & Collaborators

• MTI University: lead

Related Links

• EFFECT OF TRANSDERMAL INSULIN DELIVERY BY LOW INTENSITY ULTRASOUND IN HEALING OF CHRONIC LOWER LIMB VENOUS ULCER

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Bandages

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

amira saad Mohamed, Master degree

CONTACT

02-01092128481; amira.saad.mm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Basic Science Department, Faculty of Physical Therapy Modern University for Technology and Information

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11