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

Study Overview
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Brief Summary
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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

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

Conditions
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Wound Heal

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Selenium


Participation Criteria
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Eligibility Criteria
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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: Wagner's grade 5 patients (because of the indications for amputation). Patients with poor glycemic control at the time of inclusion (HbA1c>12%). Patients who need either direct graft or indirect revascularization procedure during the study. Patients with Cilostazol or Selenium allergy. Patients with Cilostazol contraindications (Heart Failure, bleeding disorder). Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure). Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever). Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion. Non-diabetic patients with foot wounds due to vascular or dermatological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |