Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
β 肾上腺素能拮抗剂用于治疗慢性糖尿病足溃疡
基本信息
- 批准号:10417105
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-04-01 至 2024-03-31
- 项目状态:已结题
- 来源:
- 关键词:Adrenergic beta-AntagonistsAdverse eventAffectAmputationAnalysis of CovarianceAnalysis of VarianceAnimal ModelBasic ScienceBlindedCaliforniaCaringCellsCharacteristicsChronicClinicClinicalClinical DataClinical ManagementClinical ResearchClinical Trials Cooperative GroupColon CarcinomaControl GroupsCutaneousDataDebridementDermatologicDevicesDiabetes MellitusDiabetic Foot UlcerDiseaseDouble-Blind MethodDrainage procedureDropsEligibility DeterminationEnrollmentEpithelialEyedropsFoot UlcerFunctional disorderGelGlaucomaHealth SurveysHealthcareHealthcare SystemsHomeHumanHydrogelsImpaired healingIn VitroIndividualInformed ConsentIsopropanolKnowledgeLaboratoriesLaboratory AnimalsLaboratory ResearchLegLogistic RegressionsLower ExtremityMeasurementMeasuresMedical Care CostsMedicineMethodsMorbidity - disease rateOutcome MeasurePatientsPersonsPharmaceutical PreparationsPhasePlacebosPopulationProductivityQuality of lifeRandomizedRandomized Controlled TrialsRecurrenceReportingResearchResearch DesignResearch PersonnelRiskSafetySample SizeSerumSideSkinSodium ChlorideSterile coveringsStrawberry nevusSurfaceSystemTestingTherapeuticTherapeutic Human ExperimentationTimeTimololTopical applicationTranslatingTraumaUlcerUnited StatesUnited States Department of Veterans AffairsVeteransVisitWagesWorkangiogenesischronic woundcomorbidity Indexcostdiabeticdiabetic patientdiabetic ulcerearly phase clinical trialfollow-uphealingimprovedkeratinocytelifetime risklimb amputationmigrationmortalitynecrotic tissuenovel strategiesnovel therapeuticspandemic diseasepressureprimary endpointpsychologicrecidivismrecruitresponsescreeningsecondary endpointsecondary outcomesocialstandard of carestudy populationsuccesstranslational studytreatment armtreatment groupwoundwound carewound closurewound healing
项目摘要
Intro: This study will investigate the safety and efficacy of using timolol, a non-selective beta
adrenergic antagonist (BAA), topically to treat diabetic foot ulcers. We hypothesize that topical
timolol is more effective in achieving wound closure than using the standard of care (SOC)
treatment for diabetic foot ulcers, and is a safe therapeutic alternative.
Research Design/Methods: The study is a Phase 2 randomized, double blinded, controlled
and parallel-group clinical trial with 2 treatment arms, receiving either the SOC plus topical
Timoptic-XE® or a control group receiving SOC plus a non biologically active gel (hydrogel, as
placebo medicine).
The study population will be selected from the VA Northern California Health Care System,
Veterans who present with diabetic foot ulcers. We will require 24 subjects enrolled in each
treatment arm, for a total of 48 sample size to provide a power of 80% to detect a 43 %
difference, with 63% healing in the timolol group and 20% with the standard of care, at a
significance level 0.05 and an overall attrition will be 35%.
We will perform simple allocation of the subjects using an electronic randomization for
treatment assignment. Following recruitment, patients that have met the eligibility criteria and
signed an informed consent, will then undergo two weeks of baseline screening to screen out
rapid healers. Next, the patient will be randomly assigned treatment, with unique identifiers
assigned, with subject and investigator blinded as to treatment. Subjects will topically apply
daily either the treatment medication or the placebo on the foot ulcer for 12 weeks, or until
healed, whichever comes first.
Measurements of wound size and other data will be collected at baseline, followed by weekly
visits for 12 weeks, and then a follow-up period. The maximum study duration for any subject is
31 weeks with 3 phases (two weeks in the Screening Phase, up to 12 weeks in the Active Phase
including a confirmatory visit, followed by a second confirmatory visit a week later, and one
month and three-month in the Follow-Up Phase).
Analysis: The primary end point of wound closure (skin re-epithelialization without drainage
or dressing requirements) at 12 weeks will be analyzed using the two-sided Fisher's exact test.
Secondary outcomes such as the rate of ulcer healing by the 12th week of care, time to achieve
complete ulcer closure, recidivism, occurrence of adverse events will be analyzed with p- value
adjustments. A two-way ANOVA with a post hoc test will be used to relate timolol serum levels
to wound healing. The analysis of the wound characteristics, the subjects' characteristics, and
the safety parameters will be performed using logistic regression. Subjects will complete the
Veterans Rand (VR-36) Health Survey to evaluate quality of life, the Lower Extremity
Functional Scale, which will be analyzed along with the Charlson co-morbidity index, using
ANCOVA.
介绍:这项研究将研究使用Timolol(一种非选择性beta)的安全性和效率
肾上腺拮抗剂(BAA),局部治疗糖尿病足溃疡。我们假设这个话题
蒂莫洛(Timolol)比使用护理标准(SOC)更有效地实现伤口闭合。
治疗糖尿病足溃疡,是一种安全的治疗方法。
研究设计/方法:研究是一项2阶段随机,双盲,受控的
和平行组的临床试验,带有2个治疗臂,接受SOC加上局部试验
Timoptic-XE®或接收SOC的对照组加非生物活性凝胶(水凝胶,AS AS
安慰剂医学)。
研究人群将从VA北加州医疗保健系统中选出
出现糖尿病足溃疡的退伍军人。我们将需要24名受试者
治疗臂,总共48个样本量可提供80%的能力来检测43%
差异,在Timingolol组中有63%的愈合和20%的护理标准,在
显着性水平为0.05,整体损耗将为35%。
我们将使用电子随机化对受试者进行简单分配
治疗任务。招募后,符合资格标准的患者
签署了知情同意书,然后将进行两周的基线筛查以进行筛选
快速治疗者。接下来,患者将进行随机分配的治疗,并具有唯一的标识符
分配了对治疗的主题和研究人员的分配。受试者将局部适用
每天每天治疗药物或脚溃疡上的安慰剂12周,或直到
治愈,以先到者为准。
将在基线时收集伤口大小和其他数据的测量,然后每周收集
访问12周,然后进行随访期。任何科目的最大学习持续时间是
31周,有3个阶段(筛选阶段的两个星期,在活动阶段长达12周
包括确认访问,然后在一周后进行第二次确认访问,一项
在后续阶段和三个月)。
分析:伤口闭合的主要终点(皮肤再上皮无排水
或敷料要求)在12周时将使用双面Fisher的精确测试分析。
次要结果,例如在护理的第12周之前的溃疡愈合率,达到的时间
完全关闭溃疡,累犯,不良事件的发生将以p值分析
调整。带有事后测试的双向方差分析将用于关联Timolol血清水平
伤口愈合。伤口特征,受试者特征和
安全参数将使用逻辑回归进行。主题将完成
退伍军人兰德(VR-36)健康调查以评估生活质量,下肢
功能量表,将使用Charlson合并症指数分析的功能量表。
Ancova。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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{{ truncateString('Sara Dahle', 18)}}的其他基金
Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
β 肾上腺素能拮抗剂用于治疗慢性糖尿病足溃疡
- 批准号:
10291797 - 财政年份:2018
- 资助金额:
-- - 项目类别:
Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
β 肾上腺素能拮抗剂用于治疗慢性糖尿病足溃疡
- 批准号:
10683725 - 财政年份:2018
- 资助金额:
-- - 项目类别:
Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
β 肾上腺素能拮抗剂用于治疗慢性糖尿病足溃疡
- 批准号:
9892966 - 财政年份:2018
- 资助金额:
-- - 项目类别:
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