A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants With a Clinical Outcome of "Clinical Cure"
研究概览
简要总结
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
详细描述
Infected skin ulcers in patients with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and prevent the need for amputation.
Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.
In this study, all subjects will be given the necessary supplies and taught how to take care of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a man or woman aged 18 to 80 years.
- •Has diabetes mellitus, according to the American Diabetes Association criteria.
- •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 (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).
- •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.
- •Meets the certain minimal laboratory criteria
- •Has an ankle-brachial index (ABI) ≥ 0.7 and ≤ 1.
- •(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.)
- •If female, is nonpregnant (negative pregnancy tests at the Baseline/Randomization Visit) and nonlactating.
- •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)
- •Willing to return to the study facility for the Final Study Visit.
- •Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study
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.
- •Has a known hypersensitivity to bovine collagen.
- •Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study.
- •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.
- •Has a target ulcer with a wound size > 5 × 5 cm.
- •Has gangrenous tissue of the affected limb that cannot be removed with a single debridement.
- •Has a wound associated with prosthetic material or device.
- •Received any topical or systemic antimicrobial therapy within the 2 weeks prior to study entry (Visit 1 [Day 1]).
- •Has documented osteomyelitis.
- •If severely immunocompromised, may be excluded at the discretion of the Investigator.
- •Has a history of alcohol or substance abuse in the past 12 months.
- •Is undergoing dialysis (renal or peritoneal) or has history of kidney transplant.
- •Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator.
- •Has a history of epilepsy
- •Has a history of tendon disorders related to fluoroquinolone administration
研究组 & 干预措施
A
Daily topical gentamicin sponge and standard daily wound care
干预措施: gentamicin-collagen sponge (Drug)
B
Daily oral levofloxacin 750 mg and standard daily wound care
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Number of Participants With a Clinical Outcome of "Clinical Cure"
时间窗: Final Study Visit (Day 21 [or 28 or 35])
Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.
次要结局
- Time to Baseline Pathogen Eradication(assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported)
- Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group(Each time point (Day 3, 7 [14 and 21 if necessary]))
- Time to Pathogen Eradication(Actual time assessed (Day 1-21)
- Time to Positive Clinical Response((Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]))
- Number of Participants With Complete Wound Closure by Each Visit(At each timepoint Day 3, 7, 14 & 21)
- Time to Clinical Cure(Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]))