EUCTR2008-001376-73-GB进行中（未招募）不适用
A Randomized, Controlled, Open-Label Study to Investigate the Safety and Efficacyof a Topical Gentamicin-Collagen Sponge (Collatamp® G) in Combination WithAntimicrobial Therapy Compared to Antimicrobial Therapy Alone in DiabeticPatients with Moderately Infected Lower Extremity Skin Ulcers - N/A
Innocoll Technologies0 个研究点目标入组 75 人开始时间: 2008年10月15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
- 75
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
- •Is a man or woman aged = 18 and = 80 years.
- •2. Has diabetes mellitus, according to the American Diabetes
- •Association criteria.
- •3. Has a single infected skin ulcer below the knee, defined as
- •moderate” by the Infectious Disease Society of America (IDSA)
- •Guidelines for whom, in the Investigator’s opinion, intravenous (IV)
- •or oral antimicrobial therapy is appropriate (IDSA Guidelines, CID
- •204;39:885-910).
- •Moderate infection severity guideline: Infection in a patient who is
- •systemically well and metabolically stable characterized by the
- •presence of = 2 manifestations of inflammation (purulence or
- •erythema, pain, tenderness, warmth, or induration) that has = 1 of
- •the following characteristics: cellulitis extending 2 cm,
- •lymphangitic streaking, spread beneath the superficial fascia,
- •deep-tissue abscess, gangrene, and involvement of muscle, tendon,
- •joint or bone.
- •4. Has had an x-ray of the infected area within the 2 days immediately
- •preceding or at Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis. Patients with osteomyelitis
- •must receive appropriate surgical intervention to remove all necrotic
- •and infected bone and otherwise meet enrollment criteria before
- •being enrolled in the study.
- •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.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase
- •(AST) within 3x the upper limit of normal (ULN).
- •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 limb with ulcer.)
- •7. If female, is nonpregnant (negative pregnancy test results 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 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
- 另有 5 项未显示
排除标准
- •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
- •4. Has a target ulcer with a wound size > 10 × 10 cm.
- •5. Has gangrenous tissue of the affected limb that cannot be removed
- •with a single debridement.
- •6. Has wound known to contain isolates resistant to levofloxacin.
- •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. If severely immunocompromised, may be excluded at the discretion of the Investigator.
- •10. Has a history of alcohol or substance abuse in the past 12 months.
- •11. Has serum creatinine > 3 mg/dL, is undergoing dialysis (renal or
- •peritoneal) or has a history of kidney transplant.
- •12. Has a history of myasthenia gravis or other neurological condition
- •where gentamicin use is contraindicated as determined by the
- •Investigator.
- •13. Has a history of epilepsy
- •14. Has a history of tendon disorders related to fluoroquinolone
- •administration
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