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

Phase 2

Completed

• Conditions: Wound Heal
• Interventions: Drug: Cilostazol; Drug: Selenium

• Registration Number: NCT06117436
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cilostazol Group	Cilostazol	patients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management.
Cilostazol & Selenium Group	Cilostazol	Cilostazol 100 mg tablets plus Selenium 200 mcg tablets per oral once daily, in addition to standard wound care and diabetes management.
Cilostazol & Selenium Group	Selenium	Cilostazol 100 mg tablets plus Selenium 200 mcg tablets per oral once daily, in addition to standard wound care and diabetes management.

Primary Outcome Measures

Name	Time	Method
Wound Healing size	3 months	ulcer length, width, and depth in Cm

Secondary Outcome Measures

Name	Time	Method
Occurrence of infection	3 months	any symptoms of infection Include (Redness, Edema and pain at the site of infection)
Treatment-related side effects.	3 months	by asking the patient by phone call
Effect on Matrix Metalloproteinase-9 (MMP-9) level	3 months	will be used by ELISA Kit

Trial Locations

Locations (1)

National Institute of Diabetes and Endocrinology; 🇪🇬 Cairo, Egypt