TopicalNCT07432581
Topical Insulin Dressing on Management of Diabetic Foot Ulcers
A study testing Insulin and Normal saline in people with Topical and Insulin, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Insulin and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes between the age group 18-85 years.
- Both sexes.
- Patients who were diagnosed with diabetic foot according to the 2010 Edition of the Clinical Practice Guidelines for the Prevention and Management of Diabetes Foot Complications (edited by the American Diabetes Association) presented to diabetic foot clinic on regular basis.
- Participants who were able to and willing to participate in the study voluntarily who could come for dressings on a daily basis, or patients who agreed for admission for the duration of treatment were included in the study.
- Patients having ulcer below the ankle on the dorsal or plantar aspect of the foot.
- Patients with grade I and grade II ulcers of Wegener's Classification without significant growth of granulation tissue.
- Patients with controlled blood glucose levels between 110 and 130 gm/dl. Hemoglobin A1c was 7.1 ± 0.34.
- Non heavely infected wounds without significant growth of granulation tissue.
Who cannot join
- Patients with diabetic foot ulcers of Wagner grade V.
- X-ray showing features of osteomyelitis.
- Duplex showing significant atherosclerotic changes and venous abnormalities like varicosities.
- Malnutrition and uncontrolled diabetes mellitus.
- Other clinically significant medical conditions that would impair wound healing like any hepatic, renal, immunological and neurological disease and coagulopathy.
- Patients receiving corticosteroids, other immunosuppressive agents, radiation or chemotherapy one month prior to entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Insulin Dressing on Management of Diabetic Foot Ulcers, Would it Help?
This study aimed to find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing.
Read the detailed description
Non healing foot ulcers constitute a major problem that plagues those with diabetes due to angiopathy and neuropathy. It is well known that the basic cellular and molecular mechanisms that result in wound healing involve cell adhesion, migration, proliferation, differentiation, and apoptosis.
The molecular mechanisms of insulin signaling and its metabolic effects have been well studied in its classical target tissues. Insulin stimulates the growth and development of different cell types and affects proliferation, migration, and secretion by keratinocytes, endothelial cells, and fibroblasts.
- Conditions
- Topical, Insulin, Dressing, Diabetic Foot Ulcers
- Being tested
- Insulin, Normal saline
- Medical subject headings
- Insulin Resistance, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
The ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound.
Normal salineDrug
The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes
| Study group | Role | What they receive |
|---|---|---|
| Group A (soluble insulin (Actrapid)) | Experimental | The ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound. Receives: Drug: Insulin |
| Group B (normal saline) | Active comparator | The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of diabetic foot ulcer healing
Rate of diabetic foot ulcer healing was recorded.
Measured: 12 weeks after the treatment
Secondary outcomes (1)
Need for surgical debridement
The need for surgical debridement was recorded.
Measured: 12 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TopicalStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Mohamed Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432581
- Sponsor's protocol ID
- MD-85-2023 (1-6-2023)
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Insulin Dressing on Management of Diabetic Foot Ulcers, Would it Help?
- ClinicalTrials.gov ID
- NCT07432581
- Acronym / sponsor ID
- MD-85-2023 (1-6-2023)
- Conditions
- Topical, Insulin, Dressing, Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Feb 2026 (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 find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing.
Detailed description
Non healing foot ulcers constitute a major problem that plagues those with diabetes due to angiopathy and neuropathy. It is well known that the basic cellular and molecular mechanisms that result in wound healing involve cell adhesion, migration, proliferation, differentiation, and apoptosis.
The molecular mechanisms of insulin signaling and its metabolic effects have been well studied in its classical target tissues. Insulin stimulates the growth and development of different cell types and affects proliferation, migration, and secretion by keratinocytes, endothelial cells, and fibroblasts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (soluble insulin (Actrapid)) | Experimental | Drug: InsulinThe ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound. |
| Group B (normal saline) | Active comparator | Drug: Normal salineThe ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with diabetes between the age group 18-85 years.
- Both sexes.
- Patients who were diagnosed with diabetic foot according to the 2010 Edition of the Clinical Practice Guidelines for the Prevention and Management of Diabetes Foot Complications (edited by the American Diabetes Association) presented to diabetic foot clinic on regular basis.
- Participants who were able to and willing to participate in the study voluntarily who could come for dressings on a daily basis, or patients who agreed for admission for the duration of treatment were included in the study.
- Patients having ulcer below the ankle on the dorsal or plantar aspect of the foot.
Key exclusion criteria (6 listed)
- Patients with diabetic foot ulcers of Wagner grade V.
- X-ray showing features of osteomyelitis.
- Duplex showing significant atherosclerotic changes and venous abnormalities like varicosities.
- Malnutrition and uncontrolled diabetes mellitus.
- Other clinically significant medical conditions that would impair wound healing like any hepatic, renal, immunological and neurological disease and coagulopathy.
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 |
|---|---|---|
| InsulinThe ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound. | Drug | Group A (soluble insulin (Actrapid)) |
| Normal salineThe ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes | Drug | Group B (normal saline) |
Primary outcome
Rate of diabetic foot ulcer healing
Time frame: 12 weeks after the treatment
Rate of diabetic foot ulcer healing was recorded.
1 secondary outcome
Need for surgical debridement
Time frame: 12 weeks after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Normal saline in people with Topical and Insulin, 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 25 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of diabetic foot ulcer healing (time frame: 12 weeks after the treatment). 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 25 Feb 2026.