ISRCTN75035690已完成未知
se of Nexodyn in the local standard therapy of chronic infected ulcers: an exploratory study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients legally able to give their written informed consent to the trial
- •2. Male and female patients aged =18 years with no limitation of race
- •3. Presence of a chronic wound (onset at least 4 weeks before enrolment) presenting the following characteristics:
- •3.1. Presence of infection (contamination, colonization and critical colonization) diagnosed according to clinical signs
- •3.2. Total ulcer size =5 cm2 involving the derma, without visible exposure of tendon or bone.
- •3.3. WBP score equal to B2, B3, C1, C2 or C3
- •4. Ankle Brachial Pressure Index (ABPI) =0.60 in the affected limb, for venous ulcers
- •5. Patients with clinical signs and laboratory results of atypical ulcer etiology
- •6. Patients who have access, for the duration of the study, to reliable outpatient care (self, family member, nursing staff, regular visits at hospital, etc.)
- •7. Patients who will be available for the entire study period, and will be able and willing to adhere to protocol requirements
- •Participants may have multiple ulcers but only ONE will be considered the target ulcer that must be identified prior the inclusion in the study
排除标准
- •1. Patients with wounds characterized by the presence of necrotic dry eschar
- •2. Pregnant or lactating women, and women of childbearing potential not following an adequate contraceptive method
- •3. Diagnosis or suspect of septicemia, immunodeficiency and, in patients with venous ulcers, diagnosis or suspect of autoimmune diseases
- •4. Severe chronic diseases or conditions (class IV cardiac failure, uncontrolled arterial hypertension, hepatic failure, renal failure, malignancy in advanced phase, any myelopathy, anemia, chemotherapy).
- •5. Patients on ongoing therapy with immunosuppressive drugs or who used immunosuppressive drugs in the 4 weeks previous to study entry, except the subjects with atypical ulcer etiology under immunosuppressive maintenance therapy.
- •6. Patients on ongoing therapy with systemic antibiotics or who used systemic antibiotics in the 4 weeks previous to study entry.
- •7. Patients on ongoing therapy with drugs or medical devices active on the ulcer evolution, such as, but not limited to, collagens, hydrogels, hydrocolloids, etc.
- •8. Any condition that, in the opinion of the investigator, would preclude adherence or compliance to the study (e.g. chronic alcoholism, illicit drug abuse/dependence, personality disorder, relevant cognitive impairment).
- •9. Known allergy or intolerance to ingredients or excipients of the formulation of Nexodyn.
- •10. Participation, within the past 3 months prior to the start of the study, in any clinical trial, including individuals previously enrolled in this study.
研究者
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