CTRI/2019/09/021095已完成未知
A Multicenter, randomized, open label, parallel-group, comparative, prospective clinical study to evaluate the efficacy and safety of polyherbal oil compared with betadine 10% ointment in subjects with diabetic non healing wound. - NI
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
入选标准
- •1.Subjects, male or female, aged 25 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for Glycemic control.
- •2.Subject has glycosylated Hemoglobin, HbA1C, ââ?°Â¤ 10%
- •3.Subject with diagnosis of diabetic non healing wound.
- •4.Wound size (area) is ââ?°Â¤ 25 cm2 (Post-debridement) at the screening visit.
- •5.There is a minimum 3 cm margin between the qualifying Target wound and any other wound on the specified body part, post-debridement.
- •6.Unresponsive to wound care and open for at least 10 days at the time of the Screening Visit.
- •7.Wound is non-infected as determined by clinical assessment and complete hemogram (CBC).
- •8.Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study.
- •9.Subject is able and willing to comply with Study Procedures and adhere to protocol during the Study in the opinion of Investigator.
- •10.A Subject or LAR agrees to sign informed consent form.
排除标准
- •1.Evidence of the ulcer extending to the underlying muscle, tendon, bone, ligament, Joint capsule or sinus tracts.
- •2.Actively infected wound with exposed bone.
- •3.Subject has ulcers caused by a disease other than diabetes e.g., malignant ulcerations, and ulcerations due to venous or arterial insufficiency, in the opinion of the Investigator.
- •4.Ulcer, about which the Investigator is suspicious for cancer.
- •5.Subjects with a gangrenous or ischemic ulcer.
- •6.Subject with ulcer that in the opinion of the Investigator, may need amputation.
- •7.Subject with Target wound where wound measurement is not possible, such as ulcers between toes.
- •8.Laboratory values at Screening of: Hemoglobin < 8.0 g/dL, White Blood Cells (WBC) < 2.0 X 109 cells/L.
- •9.Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing, Including but not limited to the following., Connective tissue disease, Peripheral vascular disease, Clinically significant claudication or peripheral edema on the affected limb, Acute or unstable Charcot foot, Aplastic anemia or exacerbation of sickle cell anemia, Current sepsis, End-stage renal disease, Immunosuppression, Any malignancy history
- •10.Subject has received or is currently receiving or scheduled to receive any of following medication or therapies during the course of the Study, Immune suppressants (chronic systemic corticosteroids) within 30 days of randomization visit, Revascularization surgery (e.g., angioplasty, Coronary artery bypass surgery, transmyocardial revascularization) within 30 days of randomization visit, Growth factors within 30 days of randomization visit, Bioengineered tissue or skin substitutes within 30 days of randomization visit, Application of topical steroids to the ulcer surface within 30 days of randomization visit, Use of any investigational drug(s) or therapies within 30 days of randomization visit, Use of anti-inflammatory medication after screening visit.
- •11.Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study.
研究者
相似试验
进行中（未招募）
不适用
A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNa2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patientsChronic Hepatitis C Genotype 2 and 3 patientsMedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-020034-26-PLovartis Pharma Services AG400
进行中（未招募）
1 期
A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNa2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patientsChronic Hepatitis C Genotype 2 and 3 patientsMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-020034-26-BEovartis Pharma Services AG400
进行中（未招募）
不适用
A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFN alpha-2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patientsEUCTR2010-020034-26-DEovartis Pharma Services AG400
进行中（未招募）
不适用
A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNa2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patientsChronic Hepatitis C Genotype 2 and 3 patientsMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-020034-26-GBovartis Pharma Services AG400
进行中（未招募）
不适用
A multicenter, randomized, open label, parallel-groupphase IIB study on the efficacy and safety of oral regimensof DEB025 alone or in combination with ribavirin versusStandard of Care (peg-IFNa2a plus ribavirin) in treatmentnaïvehepatitis C genotype 2 and 3 patientshepatitis C genotype 2 and 3MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-020034-26-ITOVARTIS FARMA400