Efficacy and Safety of Heberprot-P® in Patients With Advanced Diabetic Foot Ulcer in Dasman Diabetes Institute. Demonstrative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Proportion of patients with 100% of the lesion area covered by granulation tissue.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.
详细描述
Diabetic foot ulcers constitute an important medical problem in the patients with diabetes mellitus. The epidermal growth factor (EGF) stimulates the proliferation of fibroblasts, keratinocytes and vessel endothelial cells, which contributes to its healing properties.In previous phase I-III clinical studies in patients with diabetic foot ulcers grade 3 and 4 of the Wagner's classification (Meggitt-Wagner classification), it has been demonstrated that the intralesional administration of the EGF stimulates the healing, having as result the formation of a useful granulation tissue in the bed of the ulcers and the later closure of the lesion. This effect was associated with a decreased risk of amputation. Considering the pharmacological actions identified for the EGF, the pathogenesis of the disease, previous clinical results and the absence of an effective treatment for this condition justifies the current clinical study. The purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.
A demonstrative study, open, single-center, uncontrolled, with one treatment group to be conducted in a maximum of 50 patients with DFU. The study will be conducted at DDI, Kuwait.
General objective To assess the efficacy and safety of the intralesional administration of Heberprot-P® plus the standard treatment in patients with diabetic foot ulcer in University of Texas Wound Classification AI-AII and CI-CII and risk of major amputation.
Specific objectives To determine the efficacy of Heberprot-P® in patients with diabetic foot ulcer in terms of the proportion of patients that reach complete response (100% of the area covered by granulation tissue) at the end of treatment.
To determine the time to reach the granulation tissue 100% of the lesion area. To assess the effect of the administration of Heberprot-P® in the prevention of major amputations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetic foot ulcer,University of Texas Wound Classification AI-AII and CI-CII with or without ischemia at least of 4 weeks of evolution Ulcers with an area between ≥ 2 cm2 or greater (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue) Patients with age than 22 years. Voluntariness of the patient by signing up the informed consent, and written form signed the date prior to study.
排除标准
- •Hemoglobin ≤100 g/L. Patients with a significant acute cardiovascular event (Major Acute Cardiovascular Event) within 3 months prior such as acute myocardial infarction, severe angina pectoris, acute stroke or transient ischemic attack, and/or thrombo-embolism event.
- •Patients with chronic uncompensated diseases: diabetic coma, or renal failure (creatinine 200 mmol/L and oligoanuria).
- •Antecedents or suspicion of malignant diseases (general physical examination, rectal tact, examination of breast, abdominal ultrasound, thorax radiography and blood hemochemistry).
- •Psychiatric diseases that compromise the treatment or the evaluations Infection Pregnancy or breastfeeding.
结局指标
主要结局
Proportion of patients with 100% of the lesion area covered by granulation tissue.
时间窗: The total duration of patient participation in the study will be 8 weeks for intervention or earlier if they show 100% granulation. Patients will be followed up until 20 weeks for final assessment
Lesion area granulation will be assessed as: Non response (0%-25%); Minimal (25%-50%); Partial (50%-75%); Total (75%-100%)
次要结局
- Need of major amputation(20 weeks)
- Adverse events(20 weeks)
- Time in which the formation of the granulation tissue 100%(8 weeks)