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

• Status: Recruiting
• Trial end date: 2025-12-03
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Cilostazol; Selenium

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.