EUCTR2006-002758-31-DE进行中（未招募）不适用
A randomized, double-blind, multi-centre, placebo-controlled, parallel-group study to examine the efficacy and safety of low dose Epoetin beta on wound healing in diabetes patients with foot ulcer
EPOPLUS GmbH & Co.KG0 个研究点目标入组 140 人开始时间: 2006年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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.Diabetic patients with foot ulcer below the ankle will be randomised into 2 treatment arms:
- •a.diagnosis of diabetes and neuropathic ulcer Wagner I or II (as indicated by a neuropathy deficit score 6-10, palpable foot pulses and an ABI-index =1.0) or
- •b.diagnosis of diabetes and ulcer Wagner I / II or wounds after amputations in patients with peripheral arterial occlusive disease (as indicated by the presence of one of the following: missing foot pulses and an ABI-index =0.8), or a history of insufficient vascularisation on the target leg*).
- •*Angiographically documented peripheral arterial occlusive disease and no surgical or endovascular treatment option.
- •2.Ulcer size over 0.5 cm2.
- •3.Male or female aged = 18 years.
- •4.Signed written informed consent to participate in this trial.
- •5.Female of childbearing potential with a negative pregnancy test, and agrees to use an acceptable contraceptive method (hormonal or IUD) throughout the study.
- •6.HbA1c < 10% or, if > 10% then stable blood glucose level within the last 4 weeks, i.e. fasting blood glucose value < 160 mg/dl.
- •7.At least one foot ulcer, the size of which can be documented using a transparent foil.
- •8.Weight between 55 kg and 160 kg.
- •9.Patients without significant healing after a 4 week Run-In period, can be randomized into a treatment arm.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant or nursing women.
- •2.Myeloplastic or proliferative disease.
- •3.Known infection with hepatitis B or hepatitis C or HIV.
- •4.Therapy with rHuEPO or analogic medicine within the last 6 months.
- •5.Bleeding episodes which affect the Hb value or known gastro-intestinale bleedings within the last 3 months.
- •6.Known or suspected intolerance to erythropoetic factors, e.g. NeoRecormon®, Aranesp®, Erypo®.
- •7.Treatment with systemic chemotherapy or radiotherapy or immunosuppressives or systemic corticosteroids within the last 6 months prior to treatment start.
- •8.Previous therapy with growth factors, e.g. GM-CSF, VEGF in the last 6 months.
- •9.Intake of any medication which interacts with epoetin beta (e.g. Cyclosporin).
- •10.Uncontrolled systolic blood pressure > 160 mmHg (supine) and/or diastolic blood pressure > 100 mmHg.
- •11.Pulmonary embolism and deep leg venous thrombosis with a history of venous thromboembolic disease.
- •12. Stroke, instable angina pectoris, STEMI or NSTEMI within the last 3 month.
- •13.Psychiatric disease or chronic cerebellar fits.
- •14.Scheduled for vascular surgery or any other intervention surgery within 4 weeks to trial start or during the trial or patients, who could benefit from vascular surgery or other invasive intervention.
- •15.Thromboembolism and/or thromboses.
- •16.Atrial fibrillation or atrial septum defect.
- •17.Transient ischaemic attack (TIA) within the last 3 month
- •18.Prolonged reversible ischemic neurological deficit (PRIND) within the last 3 month
- •19.Artificial heart valves (mechanical or biological)
- •20.Alcohol or drug of abuse.
- •21.Non-compliance and/or participation in a clinical trial within the last 3 months prior to screening.
- •22.Patients in dialysis program or chronical renal failure Grad IV.
- •23.Patients with known bleedings, MCV below normal ranges, and iron deficiency anemia
- •24.Hemoglobin, hematocrit and platelet count above the upper limit of normal according to the local laboratory
- •25. At the time point of randomization wound infections treated with antibiotics.
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, multi-centre, placebo-controlled, parallel-group study to examine the efficacy and safety of low dose Epoetin beta on wound healing in diabetes patients with foot ulcerwound healing in diabetes patients with foot ulcerMedDRA version: 8.1Level: LLTClassification code 10048037Term: Wound healing disturbance ofEUCTR2006-002758-31-BGEPOPLUS GmbH & Co.KG90
进行中（未招募）
1 期
A clinical trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL)EUCTR2017-001677-16-DEGalderma S.A.86
进行中（未招募）
1 期
A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA - Safety, efficacy and pharmacokinetics of CD11301 gel in early stage CTCCutaneous T Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001677-16-FRGalderma R&D SNC112
招募中
1 期
Effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.Prevention of clinically relevant bleeding events in patients treated with direct anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extractionMedDRA version: 20.0Level: LLTClassification code: 10005114Term: Bleeding from teeth Class: 10017947MedDRA version: 20.0Level: LLTClassification code: 10071818Term: Bleeding prophylaxis Class: 10042613CTIS2023-503719-13-00Hyloris Developments356
进行中（未招募）
1 期
A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal woman taking calcium and vitamin DThe trial is Phase III.The population will be healthy post-menopausal women who are between 60 and 85 years of ageEUCTR2005-002984-10-GBordic Bioscience4,500