NCT06470087已完成不适用
A Randomized Controlled Clinical Trial Comparing High Purity Type-I Collagen-based Skin Substitute to Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers
Adichunchanagiri Institute of Medical Sciences, B G Nagara2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Percentage Wound Area Epithelialization From Week 1 Through 4
研究概览
简要总结
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.
详细描述
The purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human Amnion/Chorion Membrane in the other half.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Subjects must be at least 18 years of age or older.
- •Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- •At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area.
- •The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- •The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- •The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
- •Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
- •Transcutaneous Oxygen Measurement (TCOM) ≥30 mmHg
- •Ankle-Brachial Index (ABI) between 0.7 and 1.3
- •Peripheral Vascular Resistance (PVR): Biphasic
- •Toe-Brachial Index (TBI) ˃0.6
- •As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.
- •If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
排除标准
- •will be designated as the target ulcer.
- •The subject must consent to using the prescribed off-loading method for the duration of the study.
- •The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
- •The subject must be willing and able to participate in the informed consent process.
- •Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
- •Exclusion Criteria:
- •A subject known to have a life expectancy of <6 months.
- •If the target ulcer is infected or if there is cellulitis in the surrounding skin.
- •Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- •A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
- •A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- •Topical application of steroids to the ulcer surface within one month of initial screening.
- •A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- •A subject with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
- •A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
- •o A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
- •Women who are pregnant or considering becoming pregnant within the next 6 months.
- •A subject with end stage renal disease requiring dialysis.
- •A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- •A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
- •A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit.
结局指标
主要结局
Percentage Wound Area Epithelialization From Week 1 Through 4
时间窗: 4 weeks
Percentage wound area epithelialization from week 1 through 4 measured manually with digital photography. Calculated by using: Percentage Epithelialization=(Epithelialized Area / Total Wound Area)×100
次要结局
- Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period(4 weeks)
- Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure(4 Weeks)
研究者
Dr Naveen Narayan MS, MCh (Plastic Surgery)
Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery
Adichunchanagiri Institute of Medical Sciences, B G Nagara
研究点 (2)
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