NCT00926068Unknown2 期
Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)
HealOr33 个研究点 分布在 2 个国家目标入组 196 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 196
- 试验地点
- 33
- 主要终点
- Complete ulcer closure
研究概览
简要总结
A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.
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
- Double (Participant, Investigator)
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
- •Age between 18 and 80 years, extremes included
- •Diagnosed with Diabetes Mellitus Type 1 or Type 2
- •Having a documented single target non-healing Plantar Neuropathic Diabetic Foot Ulcer with a minimal duration of 4 weeks prior to the informed consent signature
- •Ulcer size at randomization:
- •Wagner grade 1, between 2.0 cm2 to 10 cm2, extremes included or;
- •Wagner grade 2, between 1.0 cm2 to 10 cm2, extremes included;
- •Single target, ulcer on the study foot:
- •Wagner grade 1 or;
- •Wagner grade 2 (does not involve abscess or osteomyelitis);
- •Target ulcer area decreased by ≤ 30% OR ≤ 0.1 cm/wk edge healing rate measured after debridement at screening to after debridement if clinically indicated at randomization.
- •Glycosylated Haemoglobin A1c (HbA1c) ≤ 12%;
- •Ankle to Brachial Index (ABI) on study foot:
- •0.7 ≤ ABI ≤ 1.2 or
- •ABI > 1.2 and toe pressure > 50 mm Hg (ABI measured by Doppler; toe blood pressure measured by toe cuff);
- •Diabetic Neuropathy is confirmed by neurological testing
- •Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements
- •Subject has signed the informed consent form prior to any study protocol related procedure
排除标准
- •Subjects meeting one or more of the following criteria cannot be selected:
- •Anamnesis of current or recent past (within the last 2 years) abuse of alcohol, barbiturates, benzodiazepines, amphetamines, narcotics, cocaine, psychoactive drugs or other abused substances that will interfere with treatment compliance
- •Use of growth factors, skin graft or participation in an investigational study within the last 30 days prior to the beginning of the screening period
- •Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception or females who test positive on a blood-based pregnancy test
- •Have a documented medical history of HIV, HBV or HCV
- •Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease and/or receiving dialysis
- •Anaemia (Haemoglobin < 9 gram/dL for females or Haemoglobin < 10 gram/dL for males) or White Blood Cells count > 11,000/μL or Platelets count < 100,000/μL or impaired renal function (Creatinine > 3 mg/dL) or liver function tests > 3 times upper normal lab values or any indication of malnourishment (Albumin < 2.8 g/dL) or any other clinically significant biochemistry, haematology and urinalysis tests;
- •Had any clinically significant illness during the last 4 weeks prior to the screening period;
- •Have a current malignancy or a past malignancy in the last 5 years other than Basal Cell Carcinoma or is treated by radio/chemotherapy
- •Have any signs of clinical infection in the wound (which could be linked to raised body temperature, abscess, osteomyelitis, necrosis or erythema)
- •Had any antibiotic treatment during the screening period;
- •Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
- •Is bed-ridden or unable to come to the clinic;
- •Have more than one target non-healing Diabetic Foot Ulcer per subject;
- •Plantar Neuropathic DFU is located on an active Charcot foot;
- •Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;
- •Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;
- •Glucocorticosteroid treatment (Prednisone >10 mg/day or its equivalent)
- •Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement
研究组 & 干预措施
HO/03/03 10µg
Experimental
干预措施: HO/03/03 10µg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Complete ulcer closure
时间窗: Up to 14 weeks inclusive
Time to Event Analysis that determines time for incidence of 100% study wound closure per unit of time (days) and the incidence of 100% wound closure per unit of time using the log rank test.
次要结局
- Incidence of improved ulcers
- Percent change in wound area at 4 weeks(4 weeks)
- 75% wound closure by or on Study Week 14(Up to 14 weeks inclusive)
- Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination.(14 weeks)
- Percent change in granulation tissue at 4 weeks(4 weeks)
- Incidence of 100% Closure tested by the Fisher exact 2-tailed test(Up to 14 weeks inclusive)
研究者
研究点 (33)
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