2026-526070-16-00招募中2 期
A multicenter, prospective, randomized, placebo and non-surgical standard of care (NSSOC) controlled study, performed to evaluate the safety and efficacy of EscharEx and its placebo (gel vehicle) compared to NSSOC in participants with Venous Leg Ulcers (VLU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- 1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,
研究概览
简要总结
- To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to NSSOC (Non-Surgical Standard of Care)
- To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo control and compared to NSSOC.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women, older than 18 years of age
- •Participants 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 18 months
- •The adherent necrotic/ thick slough/fibrin non-viable tissue area assessed following wound cleansing with wet gauze and sterile saline or water and mild soap, is at least 50% of the wound area (assessed by clinical evaluation)
- •Target wound surface area is in the range of 2-40 cm2 (assessed by eKare inSightTM)
- •Participant understands the nature of the procedure, is able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure.
排除标准
- •Wound size decreased by > 20% after 7 (+3/-1) days of the screening period,
- •Participants with primary lymphatic edema (Lymphedema),
- •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)18 ≤ 0.70, Skin Perfusion Pressure (SPP) ≤ 40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms
- •Participants with pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e., pseudoeschar because 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,
- •Participants with poor nutritional status: albumin < 2.5g/dl, poorly controlled diabetes mellitus (HbA1c > 12%); anemia (hemoglobin<8 g/dL); leukocyte counts < 3,000/μl or >15,000/μl; neutrophil count ≤1,000/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> x2 ULN (unless the participant receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable),
- •Participants undergoing renal or peritoneal dialysis,
- •Any known condition that would preclude safe participation in the study, e.g., significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, neoplastic disease or any immediate life threatening condition,
- •Recent history or concurrent acute injury or disease that might compromise the participant’s welfare, according to investigator discretion,
- •The participant is currently receiving, has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments at doses known to impair the wound healing processes. These include chronic systemic steroid intake of more than 10 mg prednisone (or equivalent) per day for more than 2 weeks, immuno-suppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly.
- •Participants with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2 that are between 2 cm and 5 cm away from the edge of the target wound,
- •Participants treated with Pentoxifylline within 2 weeks prior to screening,
- •Venous ablation performed within one-month prior enrollment, in an area adjacent to the target wound,
- •Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric participants, etc.),
- •Concurrent use of non-approved drugs or alcohol abuse,
- •Pregnant women (positive pregnancy test) or nursing mothers,
- •Exposure to investigational intervention within one month prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.
- •Signs of infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, cellulitis, erysipelas etc.,
- •Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,
- •Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis,
- •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,
- •Participants suffering from chronic skin disorders unrelated to the wound that are present adjacent to the wound,
- •Participants 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,
研究组 & 干预措施
EscharEx
Test
干预措施: EscharEx (Drug)
Placebo (Gel vehicle) sterile powder: Excipients only (Lactose, potassium phosphate dibasic, potassium phosphate monobasic and Guar Gum), 4g
Placebo
干预措施: Placebo (Gel vehicle) sterile powder: Excipients only (Lactose, potassium phosphate dibasic, potassium phosphate monobasic and Guar Gum), 4g (Drug)
结局指标
主要结局
1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,
1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,
2. Clinically significant changes in vital signs and clinical laboratory parameters (blood chemistry, hematology, coagulation) during the daily period,
2. Clinically significant changes in vital signs and clinical laboratory parameters (blood chemistry, hematology, coagulation) during the daily period,
3. Incidence of discontinuation due to adverse reaction during the daily period,
3. Incidence of discontinuation due to adverse reaction during the daily period,
4. Pain, as assessed by Numeric Pain Rating Scale (NPRS), until the end of the weekly visits period,
4. Pain, as assessed by Numeric Pain Rating Scale (NPRS), until the end of the weekly visits period,
5. Time to complete wound closure from the initiation of study treatment, throughout the trial,
5. Time to complete wound closure from the initiation of study treatment, throughout the trial,
6. Incidence of complete wound closure, throughout the trial,
6. Incidence of complete wound closure, throughout the trial,
7. Percent change in wound area, from baseline until the end of the Weekly Visits Period, as assessed by eKare inSightTM.
7. Percent change in wound area, from baseline until the end of the Weekly Visits Period, as assessed by eKare inSightTM.
次要结局
- 1. Incidence of complete debridement, clinically (visually) assessed during the Daily Visits Period (up to 8 applications),
- 2. Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically,
- 3. Time to the first declaration of complete debridement, from the initiation of study treatment throughout the trial,
研究者
Director, EscharEx Clinical Development Program
Scientific
Mediwound Ltd.
研究点 (5)
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