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

Wound Heal Clinical Trial

Official title:

Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117436
• Other study ID #: CSDFU81
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 19, 2023
• Est. completion date: December 3, 2025

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: Hadeer Eid Eliwa, master
• Phone: 01000617696
• Email: hadeir.eid[@]fue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 3, 2025
• Est. primary completion date: December 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Wound Heal

Intervention

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

Locations

Country	Name	City	State
Egypt	National Institute of Diabetes and Endocrinology	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing size	ulcer length, width, and depth in Cm	3 months
Secondary	Effect on Matrix Metalloproteinase-9 (MMP-9) level	will be used by ELISA Kit	3 months
Secondary	Occurrence of infection	any symptoms of infection Include (Redness, Edema and pain at the site of infection)	3 months
Secondary	Treatment-related side effects.	by asking the patient by phone call	3 months