CTRI/2009/091/000546未知2 期
Safety and efficacy of HO/03/03 in the treatment of Planatar Neuropathic Diabetic Foot Ulcers.
试验速览
- 阶段
- 2 期
- 发起方
- HealOr Ltd.
- 入组人数
- 146
- 试验地点
- 13
- 主要终点
- Complete Ulcer Closure
研究概览
简要总结
This is a prospective, double blind, randomized, placebo controlled,outpatient, parallel group comparison trial will assess the efficacyand safety of HO/03/03 10μg vs. Placebo applied topically oncedaily for up to 14 weeks in at least 146 subjects diagnosed withDiabetes Mellitus and having a single non-healing PlantarNeuropathic Diabetic Foot Ulcer.
研究设计
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
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 non-healing Plantar Neuropathic Diabetic Foot Ulcer (per subject) with a minimal duration of 4 weeks prior to the informed consent signature;
- •Ulcer size at randomization between 1.0 cm2 to 10 cm2, extremes included;
- •Single, full thickness ulcer on the study foot, depth is no more than exposed muscle ?
- •Wagner grade 1 (does not involve exposed tendon,ligament, joint capsule, fascia or bone, no abscess or osteomyelitis);
- •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 in a vascular lab);
- •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;10.Subject has signed the informed consent form prior to any study protocol related procedure;.
排除标准
- •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 (licit or illicit) that willinterfere 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 postmenopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), 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) orliver function tests > 3 times 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;
- •Ulcer involves or exposes tendon, ligament, joint, fascia or bone at wound site;10.Have any signs of clinical infection in the wound (which could be linked to raised body temperature), abscess, osteomyelitis, necrosis or erythema);11.Had any antibiotic treatment during the screening period;12.Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;13.Is bed-ridden or unable to come to the clinic;14.Have more than one non-healing Diabetic Foot Ulcer per subject;15.Plantar Neuropathic DFU is located on an active Charcot foot;16.Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;17.Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;18.Glucocorticosteroid treatment (Prednisone >10 mg/day or its equivalent);19.Ulcer decreased in size ≥ 30% during the screening period in the 2 weeks from size measurement after debridement to size at randomization;
- •Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement;.
结局指标
主要结局
Complete Ulcer Closure
时间窗: At up to 14 weeks scored dichotomously:0 - 'No Complete Closure'1 - 'Complete Closure'
次要结局
- -Time to Complete Closure and Absolute change in Ulcer Area as measure by size at baseline subtracted from size at either: Complete closure or End of trial (or last observed value; LOV)(depends on patient)
研究者
研究点 (13)
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