NCT03593369Unknown不适用
A Prospective Controlled Randomized Clinical Study Exploring The Evolution Of Wound Biomarkers With TWO Dispensing Schedules Of The KLOX LumiHeal Gel And The KT-L Lamp Versus Standard Of Care In Venous Leg Ulcers
KLOX Technologies Inc.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年7月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Assessment of biomarkers expression in biopsies and exudates of the venous leg ulcers.
研究概览
简要总结
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU). Patients will be randomized in three groups, two different dispensing schedules of KLOX BioPhotonic System in addition to Standard of Care (SOC) will be used, and SOC alone.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 85 years of age, ambulatory or hospitalized patients;
- •Patient agrees to participate in protocol schedule of visits, including follow-up evaluations;
- •Patient to be enrolled must be able to adhere to the Standard of Care and to the treatments with the KLOX LumiHeal™ Gel and the KT-L Lamp described in the protocol;
- •Patient or an authorised person must be able to read and understand informed consent, and sign or delegate signature of the informed consent form;
- •Fitzpatrick skin type I to IV;
- •Proven venous leg ulcer, clinically defined and confirmed by duplex, refilling time or venous hypertension;
- •Ulcer to be treated must be measurable and with an area between 5 and 100 cm2 inclusively, with a maximum depth of 1 cm and maximum diameter less or equal to 10 cm;
- •If applicable, patients (male a female) must be willing to adhere to a medically-accepted birth control method (verified by the Investigator);
- •Stable wound surface area with an absolute change in wound area less than 30% as measured at Baseline Visit compared to the Screening Visit.
排除标准
- •Venous leg ulcer presents for less than 4 weeks or more than 18 months at Screening;
- •The patient has more than one ulcer in the treated leg and the ulcer(s) not being assessed are within 5 cm of the targeted ulcer;
- •The ulcer to be treated requires operative debridement or revascularization;
- •The ulcer has significant necrotic tissue, as defined by more than 20% of the ulcer area after debridement;
- •Major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, palliative care, or other chronic diseases such as lupus or sickle cell anemia;
- •Patient with known moderate to severe anemia;
- •Patient with history of malignancy within the wound or patient with prior diagnosis of malignant disease who is less than one year disease-free;
- •Patient who has experienced a hip fracture in the past 3 months;
- •Patient with known osteomyelitis or active cellulitis;
- •Patients who are immunosuppressed or on high dose of chronic steroid use (defined as oral dose of 7.5 mg or more of prednisone daily, or equivalent, for more than 28 days);
- •Patient with active wound infection or with systemic infection (the patient is however eligible for re-screening after the active wound infection or the systemic infection has subsided);
- •Successful revascularization surgery of the leg with the ulcer to be treated less than 8 weeks prior to Screening;
- •Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study, or participation within the past 60 days in another interventional wound healing clinical trial;
- •History of radiation therapy to the wound region;
- •Pregnancy, or breast feeding;
- •Patients with bleeding diathesis;
- •Patients on an uncontrolled anti-coagulation therapy;
- •The subject has any physical or psychiatric condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study;
- •Concurrent disease or drugs known to induce severe photosensitivity of the skin, such as porphyria;
- •Patient has received biological-based therapy, skin grafts or Negative Pressure Wound Therapy in the ulcer to be treated within last 3 months prior to Baseline.
研究组 & 干预措施
KLOX BioPhotonic System (single treatment)+SOC
Experimental
KLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered twice weekly in association with SOC (10 patients)
干预措施: KLOX BioPhotonic System (single treatment)+SOC (Device)
KLOX BioPhotonic System (consecutive treatments)+SOC
Experimental
KLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered in two consecutive treatments (twice weekly on the first two weeks then once weekly) in association with SOC (10 patients)
干预措施: KLOX BioPhotonic System (consecutive treatments)+SOC (Device)
Standard of Care
Active Comparator
SOC only (5 patients)
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Assessment of biomarkers expression in biopsies and exudates of the venous leg ulcers.
时间窗: Up to 20 weeks
Comparison of the expression of biomarkers in biopsies and exudates of the venous leg ulcers in the three treatment groups.
次要结局
- Adverse events, Serious adverse events, device incidents and compliance.(Up to 20 weeks)
研究者
研究点 (1)
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