Wound ComplicationNCT06400082
Topical Insulin for Postoperative Wound Healing
A study testing Insulin and Povidone-Iodine in people with Wound Complication and Insulin Resistance, Diabetes, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Wound Complication, Insulin Resistance, Diabetes
- What is being tested?
- Insulin and Povidone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2023to 10 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females
- 40-60 years old
- diagnosed with type 2 DM (for the diabetic trial)
- For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 %
- haemoglobin (Hb) ≥ 12 g/dl
- Patients who had a full thickness post-operative wound of ≥10 cm
Who cannot join
- Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion.
- Patients who had hypersensitivity to insulin,
- Patients with severe infection,
- Patients with any severe organ dysfunction
- Patients who were admitted to ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial
This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.
Read the detailed description
The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University
- Conditions
- Wound Complication, Insulin Resistance, Diabetes
- Being tested
- Insulin, Povidone-Iodine
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment
Povidone-IodineDrug
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment
| Study group | Role | What they receive |
|---|---|---|
| Povidone iodine 10% | Active comparator | Not described Receives: Drug: Povidone-Iodine |
| Topical insulin | Experimental | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of Unit Healing Time index
The total healing days and the surface area of the wound will be combined to report unit healing time in units
Measured: Before and after 7 days of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start16 Apr 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies 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
- 2 parallel groups, one treated with conventional povidone iodine 10% and the other is treated with topical insulin
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Azmy Nabeh, Cairo University
- Investigators
- Omnia Azmy Nabeh, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400082
- Sponsor's protocol ID
- 16-4-2023
- Status last verified
- Aug 2024
- First submitted
- 26 Apr 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06400082
- Acronym / sponsor ID
- 16-4-2023
- Conditions
- Wound Complication, Insulin Resistance, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 6 May 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.
This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.
Detailed description
The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 parallel groups, one treated with conventional povidone iodine 10% and the other is treated with topical insulin
| Arm | Type | Receives |
|---|---|---|
| Povidone iodine 10% | Active comparator | Drug: Povidone-Iodine |
| Topical insulin | Experimental | Drug: Insulin |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both males and females
- 40-60 years old
- diagnosed with type 2 DM (for the diabetic trial)
- For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 %
- haemoglobin (Hb) ≥ 12 g/dl
Key exclusion criteria (5 listed)
- Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion.
- Patients who had hypersensitivity to insulin,
- Patients with severe infection,
- Patients with any severe organ dysfunction
- Patients who were admitted to ICU
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 |
|---|---|---|
| InsulinInsulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment | Drug | Topical insulin |
| Povidone-IodineInsulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment | Drug | Povidone iodine 10% |
Primary outcome
Calculation of Unit Healing Time index
Time frame: Before and after 7 days of therapy
The total healing days and the surface area of the wound will be combined to report unit healing time in units
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
Omnia Azmy Nabeh, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin and Povidone-Iodine in people with Wound Complication and Insulin Resistance, Diabetes, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 5 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of Unit Healing Time index (time frame: Before and after 7 days of therapy). 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 21 Aug 2024.