EUCTR2008-000207-28-GB进行中（未招募）不适用
A Randomized, Controlled, Open-Label Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge (Collatamp® G) Compared to Levofloxacin in Diabetic Patients with a Mild Infection of a Lower Extremity Skin Ulcer - NA
Innocoll Technologies0 个研究点目标入组 72 人开始时间: 2008年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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. Is a man or woman aged 18 to 75 years.
- •2. Has diabetes mellitus, according to the American Diabetes Association criteria.
- •3. Has a single infected skin ulcer below the knee, defined as mild” by the Infectious Disease Society of America (IDSA) Guidelines, for whom, in the Investigator’s judgment, topical or oral antimicrobial therapy is appropriate (IDSA Guidelines, CID 204;39:885-910).
- •Mild infection severity: The presence of = 2 manifestations of inflammation (purulence or erythema, pain, tenderness, warmth or induration) but any cellulitis/erythema extends = 2 cm around the ulcer, and the infection is limited to the skin or superficial
- •subcutaneous tissue, with no other local complications or acute, systemic illness.
- •4. Has had an x-ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.
- •5. Meets the following laboratory criteria:
- •Hemoglobin (Hb) > 10 g/dL.
- •White blood cells (WBC) = 4000 cells/mm3 and/or absolute neutrophil count (ANC) = 1500 cells/mm3.
- •Calculated creatinine clearance (CLcr) of = 20 mL/min (using the Cockroft-Gault equation).
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) within 3x the upper limit of normal.
- •Hemoglobin A1C (HbA1C) < 10%.
- •6. Has an ankle-brachial index (ABI) = 0.7 and = 1.3. (Note: Patients with ABI < 0.7 or > 1.3 may be included if they have either a transcutaneous oxygen pressure or a toe pressure = 40 mm Hg on the limb with the target ulcer.)
- •7. If female, is nonpregnant (negative pregnancy tests at the Baseline/ Randomization Visit) and nonlactating.
- •8. If female, is either not of childbearing potential (defined as postmenopausal for = 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing 1 of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
- •Oral, implantable or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit.
- •Total abstinence from sexual intercourse (= 1 complete menstrual cycle before the Baseline/Randomization Visit).
- •Intrauterine device (IUD).
- •Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
- •9. Willing to return to the study facility for the Final Study Visit.
- •10. Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has a known history of hypersensitivity to gentamicin (or other systemic aminoglycosides) or levofloxacin or drugs in the same class, or any of the test article or reference product components.
- •2. Has a known hypersensitivity to bovine collagen.
- •3. Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study.
- •4. Has an infecting pathogen known to be intermediate or resistant in vitro to levofloxacin. Patients enrolled into the study presumptively will be discontinued if their cultured organism is intermediate or resistant to levofloxacin.
- •5. Has a target ulcer with a wound size > 5 × 5 cm.
- •6. Has gangrenous tissue of the affected limb that cannot be removed with a single debridement.
- •7. Has a wound associated with prosthetic material or device.
- •8. Received any topical or systemic antimicrobial therapy within the 2 weeks prior to study entry (Visit 1 [Day 1]).
- •9. Has documented osteomyelitis.
- •10. If severely immunocompromised, may be excluded at the discretion of the Investigator.
- •11. Has a history of alcohol or substance abuse in the past 12 months.
- •12. Is undergoing dialysis (renal or peritoneal) or has history of kidney transplant.
- •13. Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator.
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