A Prospective, Single-arm, Cohort Post Market Clinical Follow Up Investigation to Follow Evolution of the Healing of Exuding Chronic Leg Ulcers Treated With RespoSorb Silicone Border and RespoSorb Silicone Dressings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Wound area reduction
研究概览
简要总结
The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit Plus Silicone Border), work in treating long lasting wounds on the lower legs or feet. The main goal of the study is to see whether these dressings help reduce wound size over time.
The study also looks at whether the dressings improve the condition of the wound and the surrounding skin. In addition, patients are asked about their experience with the dressings, including whether they help reduce pain and how satisfied patients are with the treatment.
详细描述
This prospective, non comparative, single arm clinical investigation is conducted as part of Post Market Clinical Follow up (PMCF) activities to evaluate the clinical performance and safety of two Silicone SAP dressings: RespoSorb Silicone (RSSil; also marketed as Zetuvit Plus Silicone) and RespoSorb Silicone Border (RSSB; also marketed as Zetuvit Plus Silicone Border) in the management of chronic, exuding lower extremity wounds.
Approximately 80 evaluable adult patients with a single chronic VLU or DFU will be enrolled at 7 to 10 clinical sites in Poland, including outpatient clinics and hospitals. In each dressing group, at least 35% of patients will have VLU and at least 35% DFU. Patients with VLU will receive compression therapy, and patients with DFU will use appropriate offloading devices throughout the study.
Patients will be followed for up to 6 weeks or until wound healing, discontinuation, withdrawal, or occurrence of an adverse event preventing further participation. The primary objective is to evaluate the potential clinical effectiveness of RSSil and RSSB in reducing wound size over time. Wound area will be measured objectively by planimetry using standardized photographs taken at each visit.
Secondary outcomes include changes in wound tissue composition (granulation and slough), exudate amount and type, peri wound skin condition, frequency of dressing changes, and patient reported outcomes such as treatment benefit and wound related quality of life. Physical activity will be assessed using a wrist worn accelerometer, and compliance with compression therapy (VLU) or offloading devices (DFU) will be documented. In addition, healthcare professionals will provide feedback on usability and overall experience with the dressings.
Safety will be assessed by monitoring and recording device related adverse events and device deficiencies throughout the study. Data will be captured using an electronic case report form and analyzed primarily using an intention to treat approach.
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
- •Patient is 18 years of age or older and has given formal written consent.
- •Diagnosed with a chronic, exuding lower extremity wound of a single limb:
- •Venous leg ulcer (VLU) or
- •Diabetic Foot Ulcer (DFU).
- •Target ulcer persists since min. 1 and max. 12 months prior to screening.
- •An appropriate dressing size is available to be used according to the size of the target ulcer, the ulcer size shall be no longer than 10 cm in one dimension.
- •Target ulcer is not clinically infected ( Clinically infected wound is defined as a wound that required the use of systemic antibiotics or topical antimicrobials ).
- •Ankle-brachial pressure index (ABPI) is between 0.8 and 1.2 measured during the Screening or within 30 days prior to the Screening Visit. If ABPI is >1.2 the Toe-Brachial Index (TBI) should be >0.
- •Presence of an ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone.
- •For VLU: Patient is suitable for and agrees to use compression therapy (PütterPro2 or PütterPro2 Lite) for the study duration and was using compression therapy before study inclusion.
- •For VLU: Patient is able to walk in conjunction to compression therapy. Ankle mobility is fully mobile to limited mobile.
- •For DFU: Patient is suitable and agrees to use offloading devises for the study duration.
- •For DFU: Patient is able to walk in conjunction to offloading devices. Ankle mobility is fully mobile to limited mobile.
排除标准
- •Known allergies/hypersensitivity or intolerance to any of the study product ingredients.
- •Patients with ischemic diabetic foot ulcers.
- •Patients with more than two full-thickness lower extremity ulcers on the same limb or greater than a total of three full-thickness lower-extremity ulcers.
- •Target ulcer is clinically infected according to the judgement of HCP or suspected to be clinically infected that could require systemic antibiotics at the time of screening or during the study.
- •Treatment with local or systemic antimicrobial therapy within 7 days prior to Screening visit or during the study duration.
- •According to physician's assessment, the patient is not able to follow the study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study.
- •Patient suffers from active autoimmune disease requiring corticosteroid treatment (> 10 mg prednisolone equivalent/day) and/or other immunosuppressive (e.g. cyclosporine (>10mg/kg), methotrexate (>10mg/week), TNF inhibitors (e.g. infliximab) and/ or chemotherapy within 7 days prior to Screening visit or during the study duration.
- •Application of topical steroids to the ulcer surface 7 days prior to treatment or during the course of the study.
- •Hyperbaric treatment 7 days prior to treatment or during the course of the study.
- •Bioengineered tissue product usage on the target ulcer four weeks prior to treatment or during the course of the study.
- •Patients with clinically significant intermittent claudication (the symptoms significantly impact a person's ability to walk and perform daily activities).
- •Patients where the full dimensions of their leg ulcer could not be measured (it must be possible to display the entire wound area on one photo from a distance of 25-30 cm).
- •Wound is caused by malign tumor (primary or metastasis). Any malignancy within the past three years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
- •History of radiation to the target ulcer site within 12 months prior to screening.
- •Patients with known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV).
- •Recurrent ulcer (the target ulcer has re-occurred within 12 months after its complete closure).
- •Patients with NYHA Class IV congestive heart failure (CHF).
- •Patients with hypertensive leg ulcers (Ulcus cruris hypertonicum Martorell).
- •Patient suffers from septic phlebitis, severe deep vein thrombosis (phlegmasia cerulea dolens) or other conditions posing a contraindication for compression therapy according to established guidelines and local procedures (e.g. significant sensory neuropathy).
- •In addition to study product, further products in direct contact to wound surface will be used.
- •Documented history of osteomyelitis at the target ulcer location within six months preceding the screening visit.
- •Patients with oedema that cannot be controlled with compression therapy.
- •Patient suffers from poorly controlled diabetes (Hb1Ac ≥ 8.6%) measured within 3 months before screening or at the time of screening visit.
- •Patient suffered from significant malnutrition with reduced serum albumin levels - serum albumin concentration is below 3.5 g/dL measured within 2 weeks before screening or at the time of screening visit.
- •Patients with a known history of alcohol use disorder and substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) within the past year.
- •Participation in any interventional study in the last 7 days before beginning of this study.
- •Patients with severe obesity (BMI>40) that limited their mobility.
- •Female patients of childbearing age not using contraception, pregnancy (suspected or confirmed), or breast-feeding women.
研究组 & 干预措施
Silicone SAP Dressings (RespoSorb Silicone / RespoSorb Silicone Border)
Single-arm cohort of adult patients with chronic, exuding lower extremity wounds treated with Silicone SAP dressings. Participants receive either RespoSorb Silicone or RespoSorb Silicone Border, selected based on wound characteristics and clinical judgement, and are followed prospectively to assess wound area reduction, wound-bed condition, patient-reported outcomes, and safety.
干预措施: RespoSorb Silicone (RSSil) (Device)
Silicone SAP Dressings (RespoSorb Silicone / RespoSorb Silicone Border)
Single-arm cohort of adult patients with chronic, exuding lower extremity wounds treated with Silicone SAP dressings. Participants receive either RespoSorb Silicone or RespoSorb Silicone Border, selected based on wound characteristics and clinical judgement, and are followed prospectively to assess wound area reduction, wound-bed condition, patient-reported outcomes, and safety.
干预措施: RespoSorb Silicone Border (RSSB) (Device)
结局指标
主要结局
Wound area reduction
时间窗: Up to 6 weeks (maximum total treatment period), or until wound healing, withdrawal, or discontinuation, whichever occurs first
Clinical effectiveness will be assessed by the change in wound area of the target ulcer over time. Wound area will be calculated in square centimeters (cm²) using planimetric analysis based on standardized digital photographs taken at each study visit. The study has established a threshold for clinical significance, defining a minimum reduction in the wound area of 20%.
次要结局
- Change in granulation tissue over time(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first)
- Change in Slough Tissue Over Time(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first)
- Change in Exudate Amount Over Time(Weekly assessments during the treatment period, up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Exudate Type Over Time(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first)
- Improvement of Peri-Wound Skin Condition Over Time(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Patient-Reported Treatment Benefit (PBI-W)(Assessed at baseline and at the end of treatment at 6 weeks or until healed or withdrawal/discontinuation, whichever occurs first.)
- Quality of Life of patients with chronic wounds(Assessed at baseline and at the end of treatment at 6 weeks or until healed or withdrawal/discontinuation, whichever occurs first.)
- Change in weekly Average Active Intensity(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Active Volume(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Moderate-to-Vigorous Physical Activity (MVPA) Duration(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Active-to-Inactive Duration Ratio(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Sit-to-Stand Transitions(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Total Sleep Duration(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Sleep Efficiency(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Change in Weekly Average Sleep Onset Latency(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.)
- Social support and satisfaction assessment(Assessed once during the treatment period of 6 weeks, until healed or withdrawal/discontinuation, whichever occurs first.)
- For patients with VLU: Compliance with compression therapy(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first)
- For patients with DFU: Compliance to offloading(Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first)