EUCTR2020-003326-23-PL进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Vehicle-Controlled Study To Evaluate The Safety and Efficacy of Diperoxochloric Acid (DPOCl, DermaPro®) In Patients With Non-Healing Diabetic Foot Ulcers - Phase III Study of DermaPro® for the Treatment of Diabetic Foot Ulcer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The patient must have given written informed consent.
- •2.Age: =18 years, inclusive of the date of randomization.
- •3.Diabetic foot ulcer with mean diameter between 1.5 and 4 cm after débridement (1.5 and 4 cm if debridement is not indicated), determined as longest length + longest width)/2
- •Wound shapes other than circular must have both a length and width of at least 1.5 cm.
- •Wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification see Appendix 1), treated unsuccessfully for at least 4weeks.
- •The duration of non-healing ulcer presence prior to study should be at least 4 weeks
- •Should more than one eligible wound be present, only one will be selected by the investigator, not closer than 3 cm to adjacent ulcers (target wound”).
- •Note: Other wounds with impaired healing, e.g. decubitus ulcer, arterial and/or venous leg ulcer, Charcot's foot or malum perforans, may be present in the same patient but shall not be selected as targets for the present study.
- •4.Type 1 or type 2 Diabetes Mellitus under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) = 12% at screening. The laboratory results may not be older than 3 month at the date of randomization.
- •5.Adequate perfusion of the lower leg on the affected side determined by either:
- •an ankle / brachial ratio of > 0.7
- •or systolic blood pressure of either > 50 mm Hg (big toe)
- •or > 70 mm Hg (dorsalis pedis)
- •as determined by an appropriate method, according to local use, concerning the foot pulse to exclude patients who require a revascularization therapy; examination results should be not older than 3 months.
- •6.Females of non-childbearing potential defined as being amenorrhoeic for longer than 2 years with an appropriate clinical profile or surgically sterile.
- •If of childbearing potential the patient must use an adequate birth control and must have a negative pregnancy test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1.Clinical evidence of ulcer bed infection requiring treatment with topical or systemic antibiotics
- •2.Suspicion of bone infection or osteomyelitis* affecting the area of target wound.
- •3.An ulcer primarily ischemic in etiology
- •Note: The ulcer is primarily ischemic in etiology as diagnosed by an ABI of = 0.7 on the affected extremity or systolic pressure of = 50 mmHg (great toe) or = 70 mmHg (dorsalis pedis).
- •4.Revascularisation of the affected leg done less than 3 months before randomization or planned revascularization procedure.
- •5.Start or change of a new off-loading strategy (already existing off-loading device at the investigator´s discretion, is optimally applied and must be maintained).
- •6.Clinically significant abnormal values in clinical chemistry except those typical for the underlying diseases mentioned in the inclusion criteria (for ranges see laboratory manuals of the laboratories of the participating sites/ countries). These exceptions are at the discretion of the Investigator and taken into account the tolerated ranges given in the table in Section 11.3.9.
- •Note. Patients with a high blood glucose level are eligible, provided HbAc1 = 12% at screening.
- •7.Severe or uncontrolled heart disease (NYHA class III or IV, see Appendix 2).
- •8.Diagnosis of renal failure or treatment with dialysis.
- •9.Active severe hepatic disease, which might have an impact on wound healing.
- •10.Concurrent illness or a condition that may interfere with wound healing other than those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy).
- •11.Previous radiation of the region of the target wound selected for the study.
- •12.Exposure of any systemic immunosuppressive or cytostatic therapy or growth factors during the previous 30 days prior to the study, including the day Informed Consent is given.
- •13.Severe psychiatric or neurological disorder.
- •14.Incapability of giving informed consent.
- •15.Co-worker, student, relative or spouse of the investigator.
- •16.Previous participation in this present study.
- •17.Participation in another experimental clinical study during the previous 3 months prior to entry into the present study.
- •18.Current drug or alcohol abuse.
- •19.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
研究者
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