A Multicentric Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Percentage Change in Wound Area
研究概览
简要总结
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. 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 the present study is to compare the safety and efficacy of high-purity type-I collagen-based skin substitutes (HPTC), which are free from contaminants such as lipids, elastin, and other immunogenic particles, versus dehydrated human amnion/chorion membrane (dHACM) in the treatment of DFUs. This multicentric randomized, controlled clinical trial seeks to provide valuable insights into the best treatment strategy for enhancing healing outcomes and reducing the challenges posed by chronic DFUs.
Study will be carried out as a multicentric randomized, controlled open-label study to evaluate the safety and effectiveness of High Purity Type-I Collagen-based Skin Substitute (HPTC) compared to Dehydrated Human Amnion/Chorion Membrane (dHACM) for treating diabetic foot ulcers (DFUs). The trial will include patients with DFUs treated by wound care specialists at Adichunchanagiri Institute of Medical Sciences (AIMS), B. G. Nagara, Rajarajeswari Medical College and Hospital (RRMCH), Bangalore, JSS Medical College and Hospital (JSS), Mysore and Mysore Medical College and Research Institute (MMC&RI), Mysore, under the supervision of primary investigator Dr Naveen N. the other principal investigators include Dr Kamal Kumar M, Dr Ravi Shivaiah and Dr Vijay Kumar, respectively. Informed consent will be obtained from all participants prior to any study-related procedures at each of the 3 centres. Each patient will sign an Institutional Ethics Committee / Investigational Review Board (IEC/IRB)-approved consent form, at respective participating centres. IEC/IRB of Adichunchanagiri Institute of Medical Sciences, B. G. Nagara, will be the Designated Ethics Committee (DEC).
The study population will consist of patients seeking treatment for DFUs. Eligible patients will be those willing to participate and comply with scheduled visits on days 7, 10, 14, 17, 21, and 28. The study will include two phases: screening and treatment.
The screening phase aimed to determine patient eligibility for the treatment phase.
Centralized computer-generated block randomization, stratified by centre in a 1:1 ratio will be done. Due to the nature of the interventions, blinding of participants and clinicians is not feasible. However, outcome assessors and data analysts will be blinded to treatment allocation to minimize bias.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •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 Change in Wound Area
时间窗: 5 weeks
The primary outcome of the study will be the percentage change in wound area, assessed at 1, 2,3, and 4 weeks, and week 5 reported measured manually with digital photography.
次要结局
- Histopathological Analysis(5 days)
- Histopathological Analysis - Capillary Density (Vessels Per mm²)(5 days)
- Percentage of Participants to Obtain Complete Wound Closure(5 weeks)
- Time to Achieve Complete Wound Closure(5 weeks)
- Percentage of Participants Achieving ≥50% Wound Healing(5 weeks)
- Mean Number of Applications of HPTC / dHACM(4 weeks)
- Number of Participants With Adverse Events(4 weeks)
- Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF)(5 weeks)
- Healed Wound Appearance Assessment Using Vancouver Scar Scale(5 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