Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients

NCT ID: NCT06117436

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2025-01-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

patients will receive standard wound care and diabetes management (that includes bed rest with elevation, antibiotics, analgesics, and dressings).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cilostazol Group

patients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management.

Group Type: ACTIVE_COMPARATOR

Cilostazol

Intervention Type: DRUG

Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant

Cilostazol & Selenium Group

Cilostazol 100 mg tablets plus Selenium 200 mcg tablets per oral once daily, in addition to standard wound care and diabetes management.

Group Type: ACTIVE_COMPARATOR

Cilostazol

Intervention Type: DRUG

Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant

Selenium

Intervention Type: DRUG

Selenium 200 mcg oral tablet once daily

Interventions

Cilostazol

Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant

Intervention Type: DRUG

Selenium

Selenium 200 mcg oral tablet once daily

Intervention Type: DRUG

Other Intervention Names

cilosort

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Wagner's grade 5 patients (because of the indications for amputation).

2. Patients with poor glycemic control at the time of inclusion (HbA1c>12%).

3. Patients who need either direct graft or indirect revascularization procedure during the study.

4. Patients with Cilostazol or Selenium allergy.

5. Patients with Cilostazol contraindications (Heart Failure, bleeding disorder).

6. Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure).

7. Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever).

8. Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion.

9. Non-diabetic patients with foot wounds due to vascular or dermatological reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hadeer Eid Eliwa Ibrahim Fadel

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Diabetes and Endocrinology

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CSDFU81

Identifier Type: -

Identifier Source: org_study_id