NCT04178525终止不适用
A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
Primex ehf10 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2018年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- Difference in proportions of ulcers completely healed for experimental group compared to control group.
研究概览
简要总结
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.
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)
盲法说明
The patients, investigators and other personnel involved in the study will be blinded with respect to the study treatment of the patient, until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be given
- •Patient ≥ 18 years old
- •Diagnosed with type I or type II diabetes mellitus
- •Glycosylated haemoglobin, HbA1c, ≤ 12%
- •Presence of diabetic foot ulcer or an amputation wound that meets following criteria:
- •Size of the wound 0,5 - 12 cm^2
- •Wagner grade I or II
- •Wound is not infected
- •Wound present for at least 4 weeks
- •If multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm
- •If there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria
- •Adequate perfusion (good, strong foot pulses). If foot pulses are weak, evaluation of perfusion pressures with Doppler ultrasound is performed.
- •Able to understand and comply with the requirements of the trial
排除标准
- •Known history of alcohol or drug abuse
- •Use of any antibiotic medication within the last 7 days prior to the first application of study product
- •Patients presenting with Wagner Grade III or higher ulcer
- •Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (Hb<100 g/L), neoplasia)
- •Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
- •Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the doctor
- •Excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included)
- •Patients diagnosed with autoimmune connective tissues diseases
- •Previous treatment under this clinical protocol
- •Participation in another clinical trial up to 30 days before the randomization visit.
- •Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
- •Medical condition likely to require systemic corticosteroids during the study period
- •Allergic to shellfish, chitosan or one of ChitoCare product compounds
- •Immobile patients
- •Pregnant and lactating women
- •Significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%)
- •BMI > 39 kg/m2
结局指标
主要结局
Difference in proportions of ulcers completely healed for experimental group compared to control group.
时间窗: 10 weeks
Relative healing rate (ratio between the proportion of ulcers healed for experimental group to proportion of ulcers healed in control group (= healing rate)).
次要结局
- Difference in time to complete healing for experimental group compared to control group.(Baseline to 14 weeks (whole study duration))
- Difference in proportion of ulcers completely healed for experimental group compared to the control group(2, 4, 6 and 8 weeks)
- Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.(2, 4, 6, 8, 10 and 14 weeks)
- Difference in improved quality of life for experimental group compared to control group.(4 weeks and 10 weeks)
- Difference in improved state of the wound for experimental group compared to control group using Bates-Jensen wound assessment tool (BWAT).(2, 4, 6, 8, 10 and 14 weeks)
- Secondary infections that may occur during the study for experimental group compared to control group.(Baseline to 14 weeks (whole study duration))
- Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.(2, 4, 6, 8, 10 and 14 weeks)
- Incidence of treatment related adverse events for experimental group compared to control group.(Baseline to 14 weeks (whole study duration))
- To track diabetic ulcer recurrence for experimental group compared to control group in patients whose wound completely healed.(Baseline to 14 weeks (whole study duration))
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)Diabetic Foot UlcersNCT01490879OcuNexus Therapeutics, Inc.168
撤回
1 期
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) PatientsDiabetic Foot UlcersNCT02367690Karyopharm Therapeutics Inc
已完成
不适用
High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUsDiabetic Foot Ulcer (DFU)NCT06470087Adichunchanagiri Institute of Medical Sciences, B G Nagara28
已完成
早期 1 期
Placenta Derived Stem Cells for Treating of Chronic Ulcers and NeuropathyDiabetic NeuropathiesDiabetic Foot UlcerDiabetic FootNCT06373809Michael H Carstens20
已完成
1 期
A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot UlcerDiabetic Foot Ulcer (DFU)NCT04277598Aposcience AG159