ISRCTN11013503已完成未知
An open-label, multicentre, clinical investigation of the safety and performance of a new collagen-based, chondroitin sulfate- and chitosan-containing active wound care dressing, associated to standard of care, in the treatment of chronic, non-ischemic, non-healing diabetic foot ulcer
IBSA Institut Biochimique S.A0 个研究点目标入组 40 人开始时间: 2022年5月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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. Adult male and female outpatients aged =18 years
- •2. Subject being diagnosed with type 1 or type 2 diabetes
- •3. Subject diagnosed with plantar neuropathic DFU (positive Semmes-Weinstein 10 g Monofilament test)
- •4. Chronic DFU present from =4 weeks and = 24 weeks
- •5. DFU cross-sectional area of =1 cm² and =10 cm²
- •6. DFU of grade 1A-1B or 2A-2B according to the University of Texas Staging System for Diabetic Foot Ulcers
- •7. DFU Grade 1/uninfected or Grade 2/mild infected according to Infectious Diseases Society of America (IDSA) classification
- •8. Glycated haemoglobin HbA1c value =9% at Screening or within 3 months prior to inclusion
- •9. Presence of dorsalis and posterior tibial pulses and Ankle-Brachial Pressure Index (ABPI) value =0.9 and =1.2 at Screening or within 3 months prior to inclusion
- •10. No surgery at the limb of interest within 1 month prior to inclusion
- •11. Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- •12. Subject provided written informed consent to participate in the study obtained according to Good Clinical Practice (GCP)
- •13. Subject able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire study (including the ability to attend all the planned study visits according to the time limits, have access to the internet via a computer, iPad, iPhone or Android device), based on Investigator’s judgement
- •14. Females of childbearing potential (i.e., not permanently sterilised - post-hysterectomy or tubal ligation status – or not postmenopausal) must have a negative pregnancy test result at Screening and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline: a highly effective method is defined as those which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
排除标准
- •1. DFU of ischemic or neuroischemic origin (ABPI <0.9)
- •2. DFU which cross-sectional area diminished >30% during the 2-week run-in period of the study, i.e. between V1 and V2
- •3. Infected DFU at the end of the run-in period, i.e. V2
- •4. Superinfected DFU (Grade 3-4 according to IDSA classification) including osteitis
- •5. Presence of necrotic tissue on the target DFU bed
- •6. DFU with exposed tendon or bone
- •7. Active Charcot’s foot
- •8. Presence of more than one plantar DFU in the limb of interest
- •9. Presence of plantar DFUs in both limbs
- •Treatment-specific exclusion criteria:
- •10. Concomitant treatment or treatment within 3 months prior to the enrolment with medications known to adversely affect the healing process or suspected of compromising the subject's immune system: i.e., systemic corticosteroids, cytostatic drugs, immunosuppressive agents
- •11. Treatment with topical antibiotics in the target wound area
- •12. Allergy to components contained in the IP
- •13. History of anaphylaxis or allergic reactions to any other allergens potentially affecting the study outcome
- •General exclusion criteria:
- •14. Clinically significant or unstable underlying/concurrent disease whose sequelae or treatment might interfere with the evaluation of study parameters, including autoimmune diseases, such as rheumatoid arthritis, vasculitis; immunocompromised states, such as HIV infection
- •15. Severe anemia (haemoglobin <8 g/dl) or hypoalbuminemia (albumin <2.5 g/dl) indicating a poor nutritional status (<3 months prior to inclusion)
- •16. Subject suffering from severe hepatic disorders (with serum activity of ALT/AST =2.5 UNL) or severe renal disorders (creatinine clearance <30 ml/min) (<3 months prior to inclusion)
- •17. Presence of severe cardiac/cardiovascular conditions, i.e. NYHA Class III and IV congestive heart failure (CHF)
- •18. Subjects with a history of alcohol or drug abuse (within the previous 12 months), or heavy smoker (>25 cigarettes/day)
- •19. Major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study
- •20. Positive or missing pregnancy test at the screening visit, or breastfeeding women
- •21. Concomitant participation in other clinical trials or participation in the evaluation of any IMDs/IMPs during 3 months before this study or previous participation in the same study
- •22. Participation in the study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator
研究者
相似试验
进行中（未招募）
1 期
An open-label, multi-centre, clinical study to collect information on the clinical use of argatroban in patients with heparin induced thrombocytopenia (HIT) Type II who require parenteral antithrombotic therapy. - ARG-E07EUCTR2008-000730-42-FRMitsubishi Tanabe Pharma Corporation20
已完成
不适用
The evaluation of the effect and safety of night serum in visible signs of agingISRCTN33018063ISDIN S.A24
进行中（未招募）
1 期
Calcinosis cutis in SSc patients treated with sodium thiosulfate assessed by biomarkers and imagingCalcinosis cutis in systemic sclerosisCTIS2023-510255-34-00Aarhus Universitetshospital75
进行中（未招募）
1 期
Clinical study to evaluate the handling and safety of AVT06 PFS in subjects with chorioretinal vascular disease (ALVOEYE-D).chorioretinal vascular disease (neovascular age-related macular degeneration [nAMD], diabetic macular edema [DME], myopic choroidal neovascularization [CNV], retinal vein occlusion [RVO] and diabetic retinopathy [DR])MedDRA version: 20.1Level: PTClassification code: 10012689Term: Diabetic retinopathy Class: 100000004853MedDRA version: 20.0Level: PTClassification code: 10071129Term: Neovascular age-related macular degeneration Class: 100000004853MedDRA version: 20.0Level: PTClassification code: 10038907Term: Retinal vein occlusion Class: 100000004853MedDRA version: 20.1Level: LLTClassification code: 10057934Term: Diabetic macular edema Class: 10015919MedDRA version: 21.1Level: LLTClassification code: 10073711Term: Myopic choroidal neovascularization Class: 10015919CTIS2023-505225-13-00Alvotech Swiss AG35
进行中（未招募）
1 期
Clinical trial to evaluate the efficacy and safety of tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 StudyCOVID-19 pneumoniaMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001995-13-ESFundación SEIMC-GESIDA500