NCT06640985进行中（未招募）不适用
A Single-center Prospective Case Series Study to Determine the Efficacy and Safety of EDX110 in Hard-to-heal Wounds Resulting From Venous Insufficiency or Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs
研究概览
简要总结
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
详细描述
Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
- •An index ulcer meeting the following characteristics:
- •Diabetic foot ulcer (DFU): Wagner Grade 1: partial- or full-thickness (superficial)
- •DFU: Located on the anatomical foot; defined as distal to the medial malleolus
- •Venous leg ulcer (VLU): Partial or full thickness
- •VLU: Located below the knee and above the ankle
- •Presents with or without clinical signs of superficial infection
- •Present for ≥4 weeks and <52 weeks
- •Wounds will be dry to moderately exudating
- •Post-debridement wound area is ≥0.5 cm2 and ≤25 cm2
- •If two or more ulcers are present, the index ulcer must additionally be:
- •The ulcer with the largest wound area
- •≥3cm distance from any other ulcer on the affected limb
- •DFU: type 1 or type 2 diabetes (confirmed by the subject's medical history)
- •DFU: HgbA1c <9% at screening
- •GFR>30 mL/min/1,73m2
- •Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following results within the past 30:
- •Dorsum transcutaneous oxygen test (TcPO2): >30mmHg;
- •Subject's Ankle-Brachial Index (ABI) by Doppler: ≥0.7 and ≤1.2;
- •Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For Ankle-Brachial Pressure Index (ABPI): >1.2, for Toe Brachial Index (TBI): >0.5
- •A total lymphocyte count of more than 1500 cells/mm3
- •Albumin level of more than 3.5 g/dL
- •Subject can ambulate at home or in the clinic with or without mobility aids
排除标准
- •Subjects with wounds that have any of the following characteristics:
- •Wounds that penetrate down to tendon, ligament, joint capsule or bone, underlying muscle tissue, or organs
- •Tunnelling wounds
- •Known or suspected local skin malignancy at the site of the ulcer
- •DFU: Major structural abnormalities of the foot
- •DFU: Active Charcot deformity
- •VLU: inability to tolerate elastocompression (40 mm/hg)
- •Wound duration >1 year
- •Subjects receiving any of the following prior therapies:
- •In the last 10 days:
- •Chemical debridement
- •Dakin's solution
- •Medical honey therapy
- •In the last 30 days (or anticipated to require such medications during the study period):
- •Cytotoxic chemotherapy
- •Application of topical steroids to the ulcer surface
- •Use of ≥14 days of immune suppressants (including systemic corticosteroids) OR
- •Subject is anticipated to require such medications during the study period
- •In the last 30 days:
- •o Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials
- •In the last 6 months:
- •Any amputation to the affected leg
- •Revascularization (surgical or stenting) to the affected leg
- •Known hypersensitivity to constituents of the product
- •Osteomyelitis/bone infection of the affected foot/leg, as verified by x-ray within 30 days prior to screening
- •Active cellulitis at the wound site
- •History of radiation at the ulcer site, regardless of duration
- •Chronic kidney disease stage 4 or 5
- •Immune system disorders, including SLE, AIDS or HIV
- •Presence of any other pathology that would limit blood supply and compromise healing
- •Revascularization procedure to increase blood flow in the target limb
- •Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of, or compliance with the study
- •Women of childbearing age (women aged <55 years who have not undergone menopause) who are:
- •Pregnant at time of enrolment
- •Planning to become pregnant during the time of the study
- •Have been pregnant within the last 6 months
- •Breast-feeding
- •Unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) during the time of the study
- •Concurrent enrolment in any other study
结局指标
主要结局
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs
时间窗: 12 week
Percentage area reduction (PAR) of target wound at 12 weeks for each wound determined by wound measurements
次要结局
- Efficacy of EDX110 in complete wound management and healing of hard-to-heal wounds(4 week)
- Effect of EDX110(Treatment, week 4 and 12)
- Tolerability of EDX110(up to 12 week)
研究者
研究点 (1)
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