EUCTR2018-001725-75-HU进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1) - GAIT 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 552
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. Age 18 years or older
- •2. Established diagnosis of diabetes mellitus (type I or II)
- •3. Glycosylated hemoglobin (HbA1c) value < 12.0% at the screening visit
- •4. Diagnosis of neuropathic foot ulcer by 10 g monofilament test, tuning fork (128 Hz), or cotton wisp
- •5. Designated foot ulcer meets the following criteria at both the screening and baseline visits:
- •a. Present for at least 4 weeks
- •b. Full-thickness cutaneous ulcer below the ankle surface
- •c. University of Texas grade A1
- •d. Wound area (after debridement) 1 to 40.0 cm2
- •e. Viable, granulating wound (investigator discretion)
- •6. Ankle brachial index = 0.7 at both the screening and baseline visits. If the ABI is > 1.30, one of the following confirmatory tests must be performed for the patient to be considered eligible:
- •a. Does not have a monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, as determined by standard practices of the investigator and the site.
- •b. Transcutaneous oxygen pressure (TcPO2) at the foot >40 mmHg
- •7. Signed informed consent
- •8. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of investigational product. Male patients must also agree to use contraception such as a condom.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 152
排除标准
- •1. Change (decrease or increase) in size of the designated target ulcer by = 30% during the 7-day screening period
- •2. Cannot tolerate off-loading methods or cannot comply with study related procedures
- •3. Has an ulcer that meets any of the following criteria:
- •a. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site
- •b. Requires surgical debridement
- •c. Is positive for ß-hemolytic streptococci upon culture performed prior to screening debridement procedure.
- •d. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure
- •e. Is highly exuding (i.e., requires daily change of dressing)
- •4. Requires total contact cast
- •5. Ankle brachial pressure index < 0.7
- •6. Has a local or systemic infection or local lymphangitis = 0.5 cm
- •7. Has any 1 of the following (only 1 of the 2 tests is required):
- •a. A monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries
- •b. Transcutaneous oxygen pressure (TcPO2) at the foot < 40 mmHg
- •8. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion)
- •9. Congestive heart failure (New York Heart Association class II–IV)
- •10. Coronary heart disease with ST segment elevation myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the last 6 months
- •11. Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI
- •12. Active connective tissue disease
- •13. Acute or chronic Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination
- •14. Active treatment with systemic corticosteroids or topical corticosteroids (for treatment of the target ulcer or any area of the foot). This does not include inhaled corticosteroids or topical corticosteroids used for conditions other than treating the target ulcer or any area of the foot. (Wash out period for systemic corticosteroids is 14 days for inclusion in the study. Wash out period for topical corticosteroids (for treatment of the target ulcer or any area of the foot) is 14 days for inclusion in the study)
- •15. Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for inclusion in the study)
- •16. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
- •17. Pregnant or nursing mothers
- •18. Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)
- •19. Estimated glomerular filtration rate < 25 mL/min
- •20. Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)
- •21. Significant peripheral edema as per investigator’s discretion
- •22. Known inability or unavailability of a patient to complete required study visits during study participation
- •23. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient's medical history, which, in the opinion of the investigator, may pose a threat to patient compliance
- •24. Use of a platelet-derived growth factor within 28 days before screening
- •25. Use of any investigational drug or therapy within 28 days before screening
- •26. 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
招募中
1 期
A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with OsteoporosisPostmenopausal osteoporosisMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2021-004811-26-BGAlkem Laboratories Limited504
进行中（未招募）
3 期
A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareIdiopathic Pulmonary FibrosisJPRN-jRCT2031210008Kayamori Takefumi49
进行中（未招募）
1 期
A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with OsteoporosisMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersPostmenopausal osteoporosisEUCTR2021-004811-26-PLAlkem Laboratories Limited504
进行中（未招募）
1 期
A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with OsteoporosisPostmenopausal osteoporosisEUCTR2021-004811-26-LTAlkem Laboratories Limited504
终止
3 期
A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareIdiopathic Pulmonary FibrosisJPRN-jRCT2080225268Galapagos NV(ICCC;PPDSNBL)750