Study of the Efficacy of Topical Application of Royal Jelly and Panthenol (PedyPhar® Ointment) on the Diabetic Foot Ulcers, An Open Label, Randomized, Non-placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Healing of the Ulcer
研究概览
简要总结
Clinical Trial Phase III-b
Study Sponsor:
European Egyptian Pharmaceutical Industries
Sample Size:
120 patients (60 per arm)
Study Population:
Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed. Those patients will be recruited from patients attending the Diabetic foot Center at Faculty of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo University.
Recruitment Period: 9 months
Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.
Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever comes first
详细描述
Study Design:
This is an open label randomized non-placebo study in which 120 subjects will be randomly allocated to treatment with PedyPhar ointment or Panthenol ointment for their diabetic foot ulcer. Treatment with the ointment will be preceded by appropriate surgical treatment to remove necrotic tissue as indicated by a surgeon for foot ulcer Wagner stages 3-5. Also, diabetic status will be controlled as part of the study. Ointment in either arm will be applied to the ulcer for a maximum of 5 months or till complete healing whichever happens first.
Patients will visit study center every 2 weeks where assessment of the ulcer will be done and patient will be given the ointment for the dressing enough for 2 weeks.
Blood flow in the affected leg will be assessed besides kidney functions complete blood picture besides kidney functions. Diabetic status will be monitored every months and glycosylated hemoglobin will be done every 3 months
Study Duration: 12 months
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult diabetic foot syndrome subjects over 18 years of age of any sex
- •All stages of diabetic foot syndrome including Wagner stage 5 - Mid-foot gangrene only after appropriate surgical treatment.
- •Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome.
- •Stable metabolic and pharmacological control at recruitment and during the trial period.
- •Adequate perfusion of lower limb as measured by HHD and confirmed by APSV.
排除标准
- •Non-diabetic foot ulceration (traumatic, thermal ulceration etc)
- •Diabetic foot syndrome graded 5 on Wagner's scale - hind foot gangrene only.
- •Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure
- •Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized.
- •Presence of slough or sequestrum unless debrided.
- •Hemoglobin less than 8 g/dl unless corrected.
- •Those receiving NSAIDs, steroids or anti-mitotic drugs.
- •Septicemia patients requiring urgent amputation.
研究组 & 干预措施
Pedyphar
Ointment
干预措施: Royal Jelly and Panthenol (PedyPhar® Ointment) (Drug)
Panthenol
Ointment
干预措施: Panthenol Ointment (Drug)
结局指标
主要结局
Healing of the Ulcer
时间窗: within 5 months or complete healing whichever comes first
次要结局
- local reaction that may be due to study drug(5 months)
- reduction of infection in the ulcer site(5 months)