Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Wound Healing size
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cilostazol Group
patients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management.
干预措施: Cilostazol (Drug)
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.
干预措施: Cilostazol (Drug)
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.
干预措施: Selenium (Drug)
结局指标
主要结局
Wound Healing size
时间窗: 3 months
ulcer length, width, and depth in Cm
次要结局
- Occurrence of infection(3 months)
- Treatment-related side effects.(3 months)
- Effect on Matrix Metalloproteinase-9 (MMP-9) level(3 months)
研究者
Hadeer Eid Eliwa Ibrahim Fadel
Assistant Lecturer
Future University in Egypt