CTRI/2018/10/015923尚未招募3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 552
- 试验地点
- 19
- 主要终点
- To evaluate the efficacy of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, as measured by investigator assessment of wound closure and by other method
研究概览
简要总结
This study is a Phase 3, Randomized, Double-blind, Parallel-group, Vehicle controlled, Multicenter Study to evaluate the Efficacy and Safety of Granexin Gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone. Each patient assigned to Granexin gel plus standard-of-care or vehicle gel plus standard-of-care will have the investigational product (i.e., double-blind Granexin gel or vehicle gel) applied to the target ulcer at Day 0 and at each subsequent visit during the treatment period (i.e., Day 3 and Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 visits).Study will be conducted at 43 study centers in United States, Canada, India, Poland, Czech Republic and Hungary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years or older
- •Established diagnosis of diabetes mellitus (type I or II)
- •Glycosylated hemoglobin (HbA1c) value < 10.0% at the screening visit
- •Diagnosis of neuropathic foot ulcer by 10 g monofilament test, tuning fork, or cotton wisp
- •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)
- •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.
- •Transcutaneous oxygen pressure (TcPO2) at the foot > 40 mmHg
- •Signed informed consent
- •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.
排除标准
- •Change (decrease or increase) in size of the designated target ulcer by greater than or equal to 30 percent during the 7-day screening period
- •Cannot tolerate off-loading methods or cannot comply with study related procedures
- •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 β-hemolytic streptococci upon culture performed prior to screening debridement procedure.
- •Has greater than 50 percent slough, significant necrotic tissue, bone, tendon, or capsule exposure e.
- •Is highly exuding (i.e., requires daily change of dressing)
- •Requires total contact cast
- •Ankle brachial pressure index less than 0.7
- •Has a local or systemic infection or local lymphangitis greater than or equal to 0.5 cm
- •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 less than 40 mmHg
- •Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion)
- •Congestive heart failure (New York Heart Association class II–IV)
- •Coronary heart disease with ST segment elevation myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the last 6 months
- •Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI
- •Active connective tissue disease
- •Acute or chronic Charcot neuro-arthropathy as determined by clinical and/or radiographic examination
- •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)
- •Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for inclusion in the study)
- •Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
- •Pregnant or nursing mothers
- •Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)
- •Estimated glomerular filtration rate < 25 mL/min
- •Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)
- •Known inability or unavailability of a patient to complete required study visits during study participation
- •A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient medical history, which, in the opinion of the investigator, may pose a threat to patient compliance
- •Use of a platelet-derived growth factor within 28 days before screening
- •Use of any investigational drug or therapy within 28 days before screening
- •Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.
结局指标
主要结局
To evaluate the efficacy of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, as measured by investigator assessment of wound closure and by other method
时间窗: At Week 12
次要结局
- To evaluate the safety of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, by standard methods and immunogenicity testing(Over the 12 week treatment period)
- Incidence of complete wound closure(at Week 24 (Month 6) based on investigator assessment)
研究者
研究点 (19)
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