KCT0003467尚未招募未知
A Prospective, Randomized, Partially Double-blinded, Placebo and Active-controlled, Parallel, Multiple-dose, Matched-pairs, Single-center Phase 2 Clinical Trial to Explore Efficacy and Safety of Topical Application of EG-Decorin to Skin Graft Donor Site in Patients with Wound
Eyegene0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) arbitrary participation informed consent volunteer
- •2) 19~75 years when screening
- •3) the patient who need skin graft because of trauma, ulcer, burns, surgery incision defect
- •4) the patient who can give the following the skin graft donor site
- •(1) location: both sides leg similar location or ipsilateral(if ipsilateral donor site, the maxium distance= 3cm) leg skin graft
- •(2) 0.008~0.012 inch (0.20~0.30mm) split-thickness skin grafts (STSG)
- •(3) if the following size was content with criteria:
- •? 2 skin graft donor site areas are similar(permission within 25% difference)
- •? 2 skin graft donor site areas 38~127cm2(25% difference consideration)
- •(4) if the skin graft donor site which the previous skin graft donor site didn't give
排除标准
- •1) active systemic infection or over 38? fever lasted 3 days within 1 week before inject investigaional product
- •2) the severity of disease excluded diabetes(immune deficiency syndrom, arteriosclerosis obliterans, variceal) could be influenced wound recovery
- •3) the patient who couldn't regulate blood sugar of HbA1c= 8.5% or severe diabetes complication
- •4) B or C type hepatitis patient(exclusion healthy carrier) or evidence of HIV(Human Immunodeficiency Virus)
- •5) thyroid cancer(stage I, II papillary, follicular, medullary types), basal cell or squamous cell carcinoma not metastasize in skin, CIN and CIS of cervix, other site malignancy tumor medical history within 3 years excluded intraepithelial carcinoma
- •6) hypersensitivity reaction anamnesis
- •7) the patient didn't progress the fix period received the prohibited drug or therapy before clinical trial
- •8) the patient who injecting the comcomitant prohibied drugs
- •9) creatinine > 1.5 x ULN(upper limit of Normal)
- •10) ALT >3 x ULN(upper limit of Normal)
- •11) Total bilirubin > 3 x ULN(upper limit of Normal)
- •12) Plasma Albumin < 2g/dL
- •(1) if the patient are not injecting anticoagulant, prothrombin time/international normalized ratio (PT INR) > 1.5 x UNL(upper limit of Normal)
- •(2) the patient is relevant to the following category as the patient are injecting anticoagulant(e.g. warfarin or LMW heparin)
- •? active bleeding or hemorrhage inclination highly (e.g.: anamnesis aneurysm patient)
- •? target INR(2~3) couldn't maintain although injection the stable dose
- •14) smoker didn't stop smoking within clinical trial
- •15) the anamnesis patient who drink and other drug abuse before screening 6 months
- •16) the patient who contingently have the injection experience of psychotropic substances, narcotic analgesics before
- •screening 6 months
- •17) the psychosis or other central nerve patient who couldn't proceed the clinical trial by investigator judgment
- •18) communication impossible patient
- •19) the patient who have low understanding clinical trial or no willingness to visit or already scheduled elective surgery
- •by investigator judgement
- •20) pregnant woman or no willingness to stop breast-feeding
- •21) Not included the following criteria(in other words, the patient can participate if the following are relevent)
- •(1) menopause(non-therapy-induced amenorrhea over 12 months) woman
- •(2) infertility because of surgery(ovary or have no uterus) woman
- •(3) if man who have no any semen after man-infertility surgery have sexual relationship only one partner
- •(4) if pregnancy could be woman, woman who use the effective contraception as below.
- •? oral contraception
- •? contraception patch
- •? intrauterine device(IUD)
- •? contraception implant
- •? contraception injection(controlled-relaese)
- •? uterus hormone device
- •? tubal ligation and infertility surgery
- •(5) woman who agreed the abstinence within clinical trial
- •? the experience which the patient definitely have abstinence during all period
- •? excluded the intermittent abstinence(e.g.: ovulation, symptothermal, after ovulation) or external ejaculation
- •22) the patient who participate present participating or within 30 days after previous participation
- •23) other unsuitable cases by investigator judgement
研究者
相似试验
已完成
3 期
The Efficacy and Safety of Ivabradine Tablet in Patients with heart failureCTRI/2018/04/013464Abbott Healthcare Private Limited180
尚未招募
不适用
A Clinical Study to compare the Effects of Cilnidipine 10 mg Tablet versus Amlodipine 10 mg Tablet in Patients of Newly Diagnosed Hypertension.CTRI/2022/04/042233Dr Amey Beedkar
进行中（未招募）
不适用
A partially randomized, partially double-blind, placebo-controlled Phase II non-inferiority study to evaluate immunogenicity and safety of one and two doses of MVA-BN (IMVAMUNE™) smallpox vaccine in 18-55 year old healthy subjectsHealthy subjects - prevention of smallpox infectionMedDRA version: 8.0Level: PTClassification code 10041197EUCTR2005-001781-14-DEBavarian Nordic A/S800
进行中（未招募）
1 期
A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)EUCTR2006-004595-13-GBBayer HealthCare AG14,000
进行中（未招募）
1 期
A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)EUCTR2006-004595-13-BGBayer HealthCare AG14,000