2024-519623-23-00招募中3 期
A multicenter, prospective, randomized, double blind, placebo controlled, adaptive design study performed to evaluate the efficacy and the safety of EscharEx in debridement of Venous Leg Ulcers (VALUE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications),
研究概览
简要总结
To assess the efficacy and safety of 5% EscharEx (EX-03 formulation) compared to placebo, in wound debridement and wound bed preparation of Venous Leg Ulcers (VLU).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women, older than 18 years of age
- •Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency)
- •Wound is present for at least 4 weeks but no longer than 1 year
- •The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation)
- •Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM)
- •Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure
排除标准
- •Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period
- •Recent history or concurrent acute injury or disease that might compromise the patient’s welfare, according to investigator discretion
- •Patient is currently receiving, or has received at any time within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments known to affect the wound healing processes; these include chronic systemic steroid intake13 with topical skin changes (i.e. thin, fragile skin with multiple hematomas or previous laceration history) immuno-suppressive drugs, immunomodulating medications, chemotherapy and radiation therapy
- •Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 qcm
- •Patients treated with Pentoxifylline within 2 weeks prior to screening
- •Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.)
- •Concurrent use of non-approved drugs or alcohol abuse
- •Pregnant women (positive pregnancy test) or nursing mothers
- •Exposure to investigational intervention within three months prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study
- •Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc
- •Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending >2 cm around the wound's edge
- •Patients with primary lymphatic edema (Lymphedema)
- •Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase
- •Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy
- •Patients with skin disorders unrelated to the wound that are presented adjacent to the wound
- •Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement
- •Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone
- •Venous ablation performed within the past month in an area adjacent to the target wound
- •A significant decrease in the arterial blood flow of the extremity, as demonstrated by either Toe-Brachial Index (TBI) ≤ 0.50, Ankle-Brachial Index (ABI) ≤ 0.70, Skin Perfusion Pressure (SPP) ≤40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms
- •Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e. pseudoeschar as a result of SSD treatment)
- •History of allergy or atopic disease or a known sensitivity to pineapples, bromelain, papaya or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen
- •Patients with poor nutritional status: albumin < 2.5g/dl, poorly controlled diabetes Mellitus (HbA1c > 12%), anemia (hemoglobin<8 g/dL), a leukocyte counts < 3,000/μl or >15000/μl, neutrophil count ≤1000/ μl, platelets <100,000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 2.5 mg/dl or eGFR < 30ml/ min /1.73m2), BMI>48
- •INR>2 or PTT > x 2 ULN (unless the patient receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable)
- •Patients undergoing renal or peritoneal dialysis
- •Any condition that would preclude safe participation in the study, e.g. significant or unstable cardiac, vascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19, or any immediate life threatening condition
结局指标
主要结局
Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications),
Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications),
Incidence of complete wound closure, clinically assessed from the initiation of study treatment until the end of the Weekly Visits Period.
Incidence of complete wound closure, clinically assessed from the initiation of study treatment until the end of the Weekly Visits Period.
次要结局
- Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically
- Time to the first declaration of complete debridement, clinically assessed, from the initiation of study treatment until the end of the Weekly Visits Period
- Time to complete wound closure, clinically assessed, from the initiation of study treatment, until the end of the Weekly Visits Period
研究者
Director, EscharEx Clinical Development Program
Scientific
Mediwound Ltd.
研究点 (16)
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