A Prospective Cohort Survey of Foot and Leg Chronic Wounds Followed up to 20 Weeks After Initiation of CACIPLIQ20® add-on to Optimal Local Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 2
- 主要终点
- Rate of wound closure
研究概览
简要总结
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
This study is a prospective and standardized recording of patients' data followed in real-life conditions to appreciate the benefits of a therapeutic strategy including CACIPLIQ20® use. It also aims at collecting data to follow-up the device's efficacy and safety and estimate its cost-effectiveness.
详细描述
§ Study context:
CACIPLIQ20® is a bioengineered structural analogue of heparan sulfate glycosaminoglycans. Numerous experimental studies have provided strong evidence that CACIPLIQ20® promotes tissue regeneration by reconstructing the cellular microenvironment following tissue injury. Case studies collected in various clinical settings support the clinical interest of CACIPLIQ20® in the management of hard-to-heal chronic wounds.
CACIPLIQ20® is currently a class III CE marked medical device (NSAI-0050 CE MARK ECDEC-NL-A4) with the following indications:
Chronic ulcers showing no tendency to heal after 6 months of standard care, or still unhealed after 12 months, such as:
- Pressure ulcers;
- Peripheral arterial disease (such as Stage IV Leriche & Fontaine) ulcers;
- Diabetic ulcers (including amputation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •General Inclusion Criteria:
- •Patients justifying a treatment with CACIPLIQ20® according to a care provider.
- •Patients presenting with a chronic wound that has not shown signs of improvement following treatment for at least 6 months prior to inclusion into the study.
- •Adult patients of either gender aged at least 18 and without upper limit for age.
- •Patients having received a full written and oral information about study conduct and objectives and having given a written consent to participate according to local regulations.
- •Patients being seen as outpatients and for whom no hospitalization is expected/planned in the 6 forthcoming weeks.
- •Patients who can and are willing to be followed by a study investigator for the duration of the study.
- •Patients benefiting from a valid health insurance or social security coverage.
- •Target Wound Inclusion Criteria:
- •Current wound that has not been previously treated with CACIPLIQ20®.
- •Target wound located below the knee.
- •Target wound is either:
- •a leg ulceration predominantly of venous origin (no ischemia as previously defined) with an area >10 cm² and/or a duration of at least 5 months,
- •a leg ulceration of any size or duration, with a documented ischemic lower limb problem,
- •a foot ulceration of any size or duration, documented as a diabetic foot ulceration (DFU).
- •If more than one wound is present and eligible, investigators will be required to select one as the target wound for this study. This wound should be the largest one. If wounds are of similar size, the ulceration considered by the investigator as the worst will be selected.
排除标准
- •Female patients who are pregnant, or lactating.
- •Bedridden patients unable to spend at least one hour per day sitting in a chair.
- •Patients suffering from severe cognitive problems precluding any voluntary participation to the study.
- •Patients with, according to investigator's opinion, a very poor life expectancy.
- •Patients with leg or foot ulcerations which are not of venous, arterial or diabetic origin (e.g. Martell's ulcer and related ulcers, pressure ulcers, traumatic wounds or burns)
- •Patients whose target wound is located on an amputation stump.
- •Patients presenting with a fungating wound at the time of inclusion.
- •Patients in an emergency situation and unable to give consent.
- •Patients intolerant to one of the study device components or to heparinoids.
研究组 & 干预措施
CACIPLIQ20®
Treatment of the target wound with CACIPLIQ20® in addition to optimal local care
干预措施: CACIPLIQ20® (Device)
结局指标
主要结局
Rate of wound closure
时间窗: Within 20 weeks after treatment initiation
Wound closure defined as a 100% re-epithelialization, including: * A confirmed complete closure (CCC), defined as a wound closure notified by investigator and confirmed by an independent reviewer when analysing wound photos. * A possible complete closure (PCC), defined as a wound closure notified by investigator without confirmation by the independent reviewer (either no photo or photo of too poor quality or no unambiguous confirmation). The primary endpoint is the sum of CCC and PCC.
次要结局
- Changes in the Pain Visual Analogic Scale(From baseline to wound closure or 20 weeks after treatment initiation)
- Rate of device deficiencies (DDs)(From baseline to wound closure or 20 weeks after treatment initiation)
- Time to wound closure(Within 20 weeks after treatment initiation)
- Rate of adverse events (AEs) related to CACIPLIQ20® use(From baseline to wound closure or 20 weeks after treatment initiation)
- Rate of wound closure according to the type of closure (CCC, PCC) and according to the nature of the treated wounds (Venous Leg Ulcers, Arterial Ulcers and Diabetic Foot Ulcers).(Within 20 weeks after treatment initiation)