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

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

Study Overview

• Status: Recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Drug: Cilostazol; Drug: Selenium

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hadeer Eid Eliwa, master; Phone Number: 01000617696; Email: hadeir.eid@fue.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • National Institute of Diabetes and Endocrinology
    • Contact: Amr Mahfouz, Consultant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; patients will receive standard wound care and diabetes management (that includes bed rest with elevation, antibiotics, analgesics, and dressings).
Active Comparator: Cilostazol Group; patients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management.	Drug: Cilostazol; Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant; Other Names: cilosort
Active Comparator: 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.	Drug: Cilostazol; Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant; Other Names: cilosort; Drug: Selenium; Selenium 200 mcg oral tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing size	ulcer length, width, and depth in Cm	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): December 3, 2025
• Study Completion (Estimated): December 3, 2025

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Trace Elements; Micronutrients; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol; Selenium
• Other Study ID Numbers: CSDFU81

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No