NCT02379468已完成3 期
Phase IIIb, A Prospective, Open Label, Randomized, Controlled, Parallel Group, Multicenter Clinical Trial of 3 Months Duration Comparing Topical Application of Royal Jelly and Panthenol (PEDYPHAR® Ointment) to Panthenol Ointment Only for Diabetic Foot Ulcers Treatment.
European Egyptian Pharmaceutical Industries4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the healing of foot ulceration in diabetic 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed and dated by study subject.
- •Male or Female patients.
- •Age is ≥18 years old and ≤ 70 years old.
- •Clinical diagnosis of Diabetes Mellitus Type I or II with diabetic foot ulcer. A past history of Diabetes Mellitus and/or the use of anti-diabetic medications for the treatment of Diabetes Mellitus with diabetic foot ulcer are sufficient.
- •Presence of 1 or more DFU, less than 15 cm in its biggest diameter, with a Texas University grade ≤ 2 and ≤ grade 2 according to the Wagner Grading system.
- •Diabetic foot ulcer has been present for at least 4 weeks and no more than 2 years prior to screening.
- •If there is Diabetic Foot Ulcer Infection, It must be:
- •Mild ( Presence of ≥ 2 manifestations of inflammation (purulence, or erythema, pain, tenderness, warmth, or indurations),any cellulitis/erythema extending ≤ 2 cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness).
- •Moderate Infection (as above) in a patient who is systemically well and metabolically stable but which has ≥1 of the following characteristics: cellulitis extending >2 cm, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, and involvement of muscle, tendon, joint or bone.
- •If subject is female and of childbearing potential, she agrees to use a medically acceptable physical barrier method contraceptive during the treatment phase.
- •Be willing and able to participate in the study as an outpatient, make the required visits to the study center during the treatment periods, and comply with study requirements.
- •Receiving medical care for diabetes.
排除标准
- •DFU with a Texas score >2 and > grade 2 according to the Wagner Grading system.
- •Severe Infected DFU with clinical or para-clinical findings suggesting osteomyelitis (Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia)
- •Clinically defined and documented severe arterial disease.
- •History of radiation therapy to the ulcer site.
- •If the study subject has Foot Ulcer of no diabetic pathophysiology.
- •Receiving corticosteroids or immune suppressive agents.
- •History of immune-vascular disease.
- •Known hypersensitivity to any component of Pedyphar® or Panthenol.
- •Patients undergoing hemodialysis.
- •Insufficient blood supply to Lower Limb (ankle-brachial index < 0.9).
- •Clinical findings suggesting complicated venous insufficiency of LL. Edema [Hyper pigmentation, Venous dermatitis, Chronic cellulitis, Cutaneous infarction (atrophie blanche), Ulceration]
- •Received treatment with any other investigational drug or device within the last 30 days
- •Unable to comply with the procedures described in the protocol
- •History of moderate to severe ischemic heart disease or any history of congestive heart failure, or has had a myocardial infarction within the previous 6 months.
- •Patients with a history of major hematological, renal or hepatic abnormalities.
- •Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
- •Refusal to give informed consent.
- •Pregnant or Breastfeeding subjects.
研究组 & 干预措施
Pedyphar
Experimental
Ointment
干预措施: Pedyphar Ointment (Drug)
Panthenol
Active Comparator
Ointment
干预措施: Panthenol (Drug)
结局指标
主要结局
Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment
时间窗: 12 weeks
Efficacy
Time to complete wound healing within 12 weeks before the end of treatment duration.
时间窗: 12 weeks
次要结局
- To identify the reasons of treatment failure and delayed response(12 weeks)
- To identify adverse events associated with the application of Pedyphar® ointment.(12 weeks)
- To evaluate the healing process of Diabetic foot ulcer using Pedyphar® ointment compared with Panthenol ointment regarding changes of foot ulcer dimensions from baseline visit to the end of the study.(12 weeks)
研究者
研究点 (4)
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