Wound HealPhase 2/3NCT06117436
Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients
A Phase 2/3 study testing Cilostazol and Selenium in people with Wound Heal, run by Ain Shams University at 1 site in Egypt.
Trial summary
The growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Heal
- What is being tested?
- Cilostazol and Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Oct 2023to 30 Jan 2025
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will be adult diabetic patients aged 18 years and older with non-ischemic diabetic foot ulcers Wagner's grade 2, 3, and 4.
Who cannot join
- Wagner's grade 5 patients (because of the indications for amputation).
- Patients with poor glycemic control at the time of inclusion (HbA1c>12%).
- Patients who need either direct graft or indirect revascularization procedure during the study.
- Patients with Cilostazol or Selenium allergy.
- Patients with Cilostazol contraindications (Heart Failure, bleeding disorder).
- Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure).
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- Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever).
- Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion.
- Non-diabetic patients with foot wounds due to vascular or dermatological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial
The growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. this study aims to find a novel intervention that improve wound healing in diabetic foot ulcer to improve patients' quality of life, reduce amputation rate, and reduce the mortality rate among diabetic foot ulcer patients
- Conditions
- Wound Heal
- Being tested
- Cilostazol, Selenium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called cilosort
Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant
SeleniumDrug
Selenium 200 mcg oral tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | patients will receive standard wound care and diabetes management (that includes bed rest with elevation, antibiotics, analgesics, and dressings). |
| Cilostazol Group | Active comparator | patients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management. Receives: Drug: Cilostazol |
| Cilostazol & Selenium Group | Active comparator | Cilostazol 100 mg tablets plus Selenium 200 mcg tablets per oral once daily, in addition to standard wound care and diabetes management. Receives: Drug: Cilostazol; Drug: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing size
ulcer length, width, and depth in Cm
Measured: 3 months
Secondary outcomes (3)
Effect on Matrix Metalloproteinase-9 (MMP-9) level
will be used by ELISA Kit
Measured: 3 months
Occurrence of infection
any symptoms of infection Include (Redness, Edema and pain at the site of infection)
Measured: 3 months
Treatment-related side effects.
by asking the patient by phone call
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start19 Oct 2023
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Eid Eliwa Ibrahim Fadel, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117436
- Sponsor's protocol ID
- CSDFU81
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eliwa HE, Wakeel LME, Mahfouz AA, Sayed R. Impact of Cilostazol versus Cilostazol and Selenium Combination on The Healing of Diabetic Foot Ulcer Patients: A Randomized Controlled Trial. Diabetol Metab Syndr. 2026 Jan 6;18(1):36. doi: 10.1186/s13098-025-02053-4.
PubMed 41495844
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06117436
- Acronym / sponsor ID
- CSDFU81
- Conditions
- Wound Heal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 7 Nov 2023 (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 growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. this study aims to find a novel intervention that improve wound healing in diabetic foot ulcer to improve patients' quality of life, reduce amputation rate, and reduce the mortality rate among diabetic foot ulcer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –patients will receive standard wound care and diabetes management (that includes bed rest with elevation, antibiotics, analgesics, and dressings). |
| Cilostazol Group | Active comparator | Drug: Cilostazolpatients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management. |
| Cilostazol & Selenium Group | Active comparator | Drug: Cilostazol, Drug: SeleniumCilostazol 100 mg tablets plus Selenium 200 mcg tablets per oral once daily, in addition to standard wound care and diabetes management. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be adult diabetic patients aged 18 years and older with non-ischemic diabetic foot ulcers Wagner's grade 2, 3, and 4.
Key exclusion criteria (9 listed)
- Wagner's grade 5 patients (because of the indications for amputation).
- Patients with poor glycemic control at the time of inclusion (HbA1c>12%).
- Patients who need either direct graft or indirect revascularization procedure during the study.
- Patients with Cilostazol or Selenium allergy.
- Patients with Cilostazol contraindications (Heart Failure, bleeding disorder).
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 |
|---|---|---|
| CilostazolAlso: cilosortCilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant | Drug | Cilostazol & Selenium Group, Cilostazol Group |
| SeleniumSelenium 200 mcg oral tablet once daily | Drug | Cilostazol & Selenium Group |
Primary outcome
Wound Healing size
Time frame: 3 months
ulcer length, width, and depth in Cm
3 secondary outcomes
Effect on Matrix Metalloproteinase-9 (MMP-9) level
Time frame: 3 months
Occurrence of infection
Time frame: 3 months
Treatment-related side effects.
Time frame: 3 months
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 18 Feb 2025.
- Derived from this study: PubMed 41495844Eliwa HE, Wakeel LME, Mahfouz AA, Sayed R. Impact of Cilostazol versus Cilostazol and Selenium Combination on The Healing of Diabetic Foot Ulcer Patients: A Randomized Controlled Trial. Diabetol Metab Syndr. 2026 Jan 6;18(1):36. doi: 10.1186/s13098-025-02053-4.
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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 Phase 2/3 study testing Cilostazol and Selenium in people with Wound Heal, run by Ain Shams 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 1 inclusion and 9 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 18 Feb 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wound Healing size (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06117436, which also lists 1 linked publication.
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 18 Feb 2025.