Diabetes MellitusNCT06708975
Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients
A study testing Insulin therapy phonophoresis and Hyperpolarized light therapy and Standard wound cleaning and dressing. in people with Diabetes Mellitus, run by MTI University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin therapy phonophoresis and Hyperpolarized light therapy and Standard wound cleaning and dressing.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.
Who cannot join
- patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin therapy phonophoresis, Hyperpolarized light therapy and Standard wound cleaning and dressing.
- Keywords
- diabetes mellites, Insulin Phonophoresis
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin therapy phonophoresisOther
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.Other
Hyperpolarized light therapy safely accelerates wound healing by stimulating blood circulation, reducing inflammation and relieving muscle spasms.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | subjects will receive Phonophoresis Insulin Therapy, hyperpolarized light therapy and Standard wound cleaning and dressing. Receives: 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 Receives: Other: Hyperpolarized light therapy and Standard wound cleaning and dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before first session and at the end of the treatment program (four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Fayek Hammam, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708975
- Sponsor's protocol ID
- P.T.REC/012/005342
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transdermal Insulin Therapy by Ultrasonographic in Wound Healing of Chronic Diabetic Patients
- ClinicalTrials.gov ID
- NCT06708975
- Acronym / sponsor ID
- P.T.REC/012/005342
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellites, Insulin Phonophoresis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Insulin therapy phonophoresis, Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.subjects will receive Phonophoresis Insulin Therapy, hyperpolarized light therapy and Standard wound cleaning and dressing. |
| Group B | Sham comparator | Other: Hyperpolarized light therapy and Standard wound cleaning and dressing.subjects will receive hyperpolarized light therapy and Standard wound cleaning and dressing |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.
Key exclusion criteria (1 listed)
- patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin therapy phonophoresisInsulin 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 | Other | Group A |
| 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. | Other | Group A, Group B |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- EFFECT OF TRANSDERMAL INSULIN DELIVERY BY LOW INTENSITY ULTRASOUND IN HEALING OF CHRONIC LOWER LIMB VENOUS ULCERLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin therapy phonophoresis and Hyperpolarized light therapy and Standard wound cleaning and dressing. in people with Diabetes Mellitus, run by MTI University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amira saad Mohamed, Master degree (02-01092128481, amira.saad.mm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.