Diabetes MellitusNCT05444842
Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer
A study testing insulin iontophoresis, topical insulin and conventional treatment in people with Diabetes Mellitus, run by Cairo University.
Trial summary
This study will be conducted to investigate the effect of Insulin iontophoresis mixed with oleic acid versus topical insulin in patients with chronic diabetic foot ulcer Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin iontophoresis, topical insulin and conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients had chronic wound at foot
- The patients ages were ranged from 40 to 70 years
- The subjects were chosen from both sexes
- All patients were diabetic patients
Who cannot join
- uncontrolled wound bleeding
- severe malnutrition
- severeinfection
- Immunodeficiency
- age>70 years
- renal failure
- liver dysfunction
- ischaemic limbs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer. Randomized Controlled Trial
This study will be conducted to investigate the effect of Insulin iontophoresis mixed with oleic acid versus topical insulin in patients with chronic diabetic foot ulcer
Read the detailed description
Despite insulin treatment and a meticulously controlled diet, approximately 15% of all patients with diabetes will, at some time, have non-healing wounds and this is the leading cause of lower extremity amputation. Wound healing involves cell adhesion, migration, proliferation, differentiation, and apoptosis at cellular and molecular levels. Abnormalities of distinct factors of wound healing contribute to defective wound healing in diabetes ulcers, including decreased growth factor production, angiogenic response, macrophage function, collagen accumulation, epidermal barrier.
Insulin has great effect on ulcers healing and tissue regeneration but there is a catch that insulin is a large polymer that have difficulty crossing skin barrier but with using penetration enhancers like oleic acid combined with iontophoresis helps insulin to get through skin especially that affect locally on wound not systematic. Insulin help in restoring the function and structure of the vasculature and improving angiogenesis, reduces the local wound blood glucose concentration, thus reducing the damage resulting from the accumulation of high levels of glucose metabolic intermediates, insulin is the inhibitor of three major proinflammatory transcription factors: Nuclear factor-κB, activator protein-1 and early growth response-1 (EGR-1). insulin relieves the inflammatory response and prevents an excessive inflammatory reaction. Furthermore, insulin inhibits the degradation of immune cell proteins, thus enhancing immune activity. 45 patients with diabetic feet will be assigned randomly into 3 equal group; group A will receive insulin iontophoresis for 13 sessions, group B will receive topical insulin and group C will receive saline dressing for 13 weeks
- Conditions
- Diabetes Mellitus
- Being tested
- insulin iontophoresis, topical insulin, conventional treatment
- 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 iontophoresisOther
All wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent). after cleaning the wound the insulin ions and oleic acid will be injected into the electrode of iontophoresis device (Phoresor_ IIAuto, ModelPM850, IOMED) then The device was set to the required dose of 40 mA-min, and the current intensity was gradually increased based on the subject's tolerance (ranging from 1 to 4 mA). The device computed the required time for the selected dose automatically.
topical insulinOther
All wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent) after cleaning the wound For each 10cm2 of the wound, patients will get ten units (0.1 mL) of insulin crystal in solution with 1mL saline (0.9 percent). An insulin syringe needle was used to spray the solution twice daily on the wound area.
conventional treatmentOther
All wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent) after cleaning the wound For each 10cm2 of wound 1mL 0.9 percent saline was given.
| Study group | Role | What they receive |
|---|---|---|
| insulin iontophoresis | Experimental | the patients will receive insulin iontophoresis for thirty weeks Receives: Other: insulin iontophoresis |
| topical insulin | Experimental | the patients will receive topical insulin for thirty weeks Receives: Other: topical insulin |
| conventional treatment | Active comparator | the patients will receive standard dressing and normal saline twice daily for thirty weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
life disability
disability of life will be assessed by the quality of life questionnaire; The Questionnaire included 12 main questions, addressing seven specific areas of functional health status (physical functioning, role limitations due to physical health, role limitations due to emotional problems, wound status improvement, social functioning, pain, and general health). All questions were scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores were compiled as a percentage of the total points' possible (step 1 chart). The scores from the questions that address a specific area of functional health status were then averaged together, for a final score within each of the dimensions measured (step 2 chart). All seven categories were scored in the same way at the beginning and at the end of the course of care to track the progress of them.
Measured: up to thirty weeks
healing rate
The major goal of this study was to achieve complete wound closure. The main area - final wound area (in mm2/healing time) in days was used to determine the wound healing rate, which was reported as mm2/day
Measured: up to thirty weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start5 Jul 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- insulin iontophoresis and topical insulin
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444842
- Sponsor's protocol ID
- p.t.REC/012/003670
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05444842
- Acronym / sponsor ID
- p.t.REC/012/003670
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 6 Jul 2022 (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.
This study will be conducted to investigate the effect of Insulin iontophoresis mixed with oleic acid versus topical insulin in patients with chronic diabetic foot ulcer
Detailed description
Despite insulin treatment and a meticulously controlled diet, approximately 15% of all patients with diabetes will, at some time, have non-healing wounds and this is the leading cause of lower extremity amputation. Wound healing involves cell adhesion, migration, proliferation, differentiation, and apoptosis at cellular and molecular levels. Abnormalities of distinct factors of wound healing contribute to defective wound healing in diabetes ulcers, including decreased growth factor production, angiogenic response, macrophage function, collagen accumulation, epidermal barrier.
Insulin has great effect on ulcers healing and tissue regeneration but there is a catch that insulin is a large polymer that have difficulty crossing skin barrier but with using penetration enhancers like oleic acid combined with iontophoresis helps insulin to get through skin especially that affect locally on wound not systematic. Insulin help in restoring the function and structure of the vasculature and improving angiogenesis, reduces the local wound blood glucose concentration, thus reducing the damage resulting from the accumulation of high levels of glucose metabolic intermediates, insulin is the inhibitor of three major proinflammatory transcription factors: Nuclear factor-κB, activator protein-1 and early growth response-1 (EGR-1). insulin relieves the inflammatory response and prevents an excessive inflammatory reaction. Furthermore, insulin inhibits the degradation of immune cell proteins, thus enhancing immune activity. 45 patients with diabetic feet will be assigned randomly into 3 equal group; group A will receive insulin iontophoresis for 13 sessions, group B will receive topical insulin and group C will receive saline dressing for 13 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- insulin iontophoresis and topical insulin
| Arm | Type | Receives |
|---|---|---|
| insulin iontophoresis | Experimental | Other: insulin iontophoresisthe patients will receive insulin iontophoresis for thirty weeks |
| topical insulin | Experimental | Other: topical insulinthe patients will receive topical insulin for thirty weeks |
| conventional treatment | Active comparator | Other: conventional treatmentthe patients will receive standard dressing and normal saline twice daily for thirty weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients had chronic wound at foot
- The patients ages were ranged from 40 to 70 years
- The subjects were chosen from both sexes
- All patients were diabetic patients
Key exclusion criteria (8 listed)
- uncontrolled wound bleeding
- severe malnutrition
- severeinfection
- Immunodeficiency
- age>70 years
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 iontophoresisAll wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent). after cleaning the wound the insulin ions and oleic acid will be injected into the electrode of iontophoresis device (Phoresor_ IIAuto, ModelPM850, IOMED) then The device was set to the required dose of 40 mA-min, and the current intensity was gradually increased based on the subject's tolerance (ranging from 1 to 4 mA). The device computed the required time for the selected dose automatically. | Other | insulin iontophoresis |
| topical insulinAll wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent) after cleaning the wound For each 10cm2 of the wound, patients will get ten units (0.1 mL) of insulin crystal in solution with 1mL saline (0.9 percent). An insulin syringe needle was used to spray the solution twice daily on the wound area. | Other | topical insulin |
| conventional treatmentAll wounds will be thoroughly cleansed with physiologic serum before the therapeutic treatment began (i.e., saline 0.9 percent) after cleaning the wound For each 10cm2 of wound 1mL 0.9 percent saline was given. | Other | conventional treatment |
Primary outcome
life disability
Time frame: up to thirty weeks
disability of life will be assessed by the quality of life questionnaire; The Questionnaire included 12 main questions, addressing seven specific areas of functional health status (physical functioning, role limitations due to physical health, role limitations due to emotional problems, wound status improvement, social functioning, pain, and general health). All questions were scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores were compiled as a percentage of the total points' possible (step 1 chart). The scores from the questions that address a specific area of functional health status were then averaged together, for a final score within each of the dimensions measured (step 2 chart). All seven categories were scored in the same way at the beginning and at the end of the course of care to track the progress of them.
healing rate
Time frame: up to thirty weeks
The major goal of this study was to achieve complete wound closure. The main area - final wound area (in mm2/healing time) in days was used to determine the wound healing rate, which was reported as mm2/day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing insulin iontophoresis, topical insulin and conventional treatment in people with Diabetes Mellitus, run by Cairo 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact al shaymaa sh abd el azeim, lecturer (01033771553, alshaymaa.shaaban@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
life disability (time frame: up to thirty weeks). The study lists 2 primary outcomes in all. 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 6 Jul 2022.