Phase II Study of Efficacy of Recombinant Human Platelet-derived Growth Factor (R-Pdf/Gbb) in Healing Wounds Caused by Third Degree Thermal and Electrical Burns.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Complete healing of the third degree burn wound.
研究概览
简要总结
Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet derived growth factor (R-Pdf/Gbb) has biologic activity similar to endogenous platelet derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and proliferation of cells responsible for wound repair and it augments production of granulation tissue.
The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III and IV. The nature of wounds in the third degree burns is similar so far as healing process is concerned.
The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0.01% gel on the third degree thermal and electrical burns will heal these wounds within 3 months and there will be improvement in general condition of the patients without any complications.
详细描述
The R-Pdf/Gbb is recombinant human platelet-derived growth factor. It has been demonstrated that rhPDGF is effective in enhancing wound healing.
OBJECTIVE
The primary objective of the study is to determine the efficacy of R-Pdf/Gbb gel in treating wounds caused by III degree thermal and electrical burns.
HYPOTHESIS 1: That the applications of R-Pdf/Gbb 0.01% gel on III degree thermal and electrical burns will heal these wounds within 3 months.
HYPOTHESIS 2: Subjects, who having III degree thermal and electrical burns with the treatment of R-Pdf/Gbb 0.01% gel, will show improvement in general condition without any complications.
We aim to test these hypotheses by evaluating the clinical outcome in about 120 patients after three months of treatment with R-Pdf/Gbb 0.01% gel applied once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to sign Informed consent.
- •Patients of both genders.
- •Patients between ages of 18 to 75 years.
- •Patients having third degree wounds caused by thermal and electrical burns.
- •Patients not willing to undergo skin grafting.
- •Patients with multiple wounds are considered but each burn wound surface area will be less than 1-8 cm
- •Wounds with adequate perfusion as assessed with the help of laser Doppler flowmeter.
排除标准
- •Patient refuses to sign informed consent.
- •Burnt wounds severity less/more than III degree (i.e. I, II, IV degree burns).
- •Patients having known neoplasm at the site of application.
- •Patients with low serum proteins.
- •Patients with uncontrolled hyperglycemia.
- •Patients who are taking Ibuprofen.
- •Patients with known hypersensitivity to parabens.
- •All other burns except thermal and electrical burns.
- •Neurological or psychiatric pathologies.
- •Women who are pregnant or nursing and women of child bearing age, who are not taking contraceptives or not willing to use them for the period of treatment.
- •Local or systemic infection
- •Conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
结局指标
主要结局
Complete healing of the third degree burn wound.
时间窗: 3 months.
次要结局
- Improvement in general condition of the study subjects without any complications.(3 months.)