Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 30
- 主要终点
- Complete wound healing
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.
详细描述
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.
Primary Objective:
The COMS One Therapy System is intended to promote wound healing in chronic DFUs. As part of the clinical investigation, the primary objective is to determine time to complete wound healing, defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
Secondary Objectives:
Secondary objectives are confirmation of safety and assessment of wound healing parameters as well as subject and site reported outcomes.
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
- Double (Participant, Investigator)
盲法说明
Permuted block randomization will be applied to generate randomization codes using a mix of blocks of size 2 and 4. Randomization will be stratified by site and age (<65 years, ≥65 years). Both the COMS One device and the Sham device will be prepared to appear to be identical to the subject to achieve the double-blind purposes and each device will be given a unique serial identifier.
To avoid assessment bias, each site will have an Inter-observer (blinded assessor) who will be blinded to treatment and perform and document all assessments of the target DFU evolution. Following target DFU assessment, the treatment will be performed by another assigned clinician, who will not have any involvement with the Inter-observer. Furthermore, both parties will be instructed not to discuss target DFU evolution or treatment with each other. This will provide an adequate level of masking to ensure that the trial is double-blinded.
入排标准
- 年龄范围
- 22 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are male or female, ≥22 and ≤90 years of age
- •Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.
- •The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)
- •Type 1 or Type 2 diabetes mellitus
- •Presence of one full-thickness DFU located at or below the malleoli (If the subject has more than one DFU that meets eligibility criteria, the investigator will designate one DFU as the target DFU to be treated in the trial)
- •Wagner Grade 1 or 2 (without bone exposure)
- •There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
- •Target DFU duration >30 days and <52 weeks
- •Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
- •Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) >0.7 but less than 1.2 or a toe-brachial index (TBI) >0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) >40mmHg
排除标准
- •Known pregnancy or lactating
- •Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
- •Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
- •Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
- •Wagner Grade 3, 4 or 5
- •Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
- •Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
- •Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
- •Subject is being treated with systemic corticosteroids (prednisone, dexamethasone, hydrocortisone, methylprednisolone, or similar) >10mg/day for more than 10 days or any dose >30 days
- •For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization/Baseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization/Baseline Visit (measured post-debridement)
- •For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization/Baseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization/Baseline Visit (measured post-debridement)
- •Blood chemistry or counts values as follows (based on subject's medical files):
- •Pre-albumin <10 mg/dL OR albumin <2.8 g/dL
- •Serum BUN >60 mg/dL
- •Serum creatinine >4.0 mg/dL
- •WBC <2.0 x 109/L
- •Hemoglobin <8.0 g/dL
- •Absolute neutrophil <1.0 x 109/L
- •Platelet count <50 x 109/L
- •HbA1C >12%
研究组 & 干预措施
COMS One device
The COMS One device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The COMS One device is reusable (the component can be used on multiple subjects and is cleaned between uses).
The COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the COMS One device.
The COMSfix component is a self-adhesive single-use strap used to hold the COMS One device and COMStouch components in place during treatment.
干预措施: COMS One device (Device)
Sham device
The sham device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The sham device is reusable (the component can be used on multiple subjects and is cleaned between uses).
The COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the sham device.
The COMSfix component is a self-adhesive single-use strap used to hold the sham device and COMStouch components in place during treatment.
干预措施: Sham device (Device)
结局指标
主要结局
Complete wound healing
时间窗: 24 weeks post-application
The primary endpoint for this pivotal trial is time to complete wound closure from randomization through 24 weeks, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
次要结局
- Partial wound closure(8 week, 12 week, 16 week, 20 week and 24 week)
- Incidence of complete wound closure(8 week, 12 week, 16 week, 20 week and 24 week)
- Time to ≥50% wound area reduction(Through 24 weeks)
- Time to ≥90% wound area reduction(Through 24 weeks)
- Incidence of all related or serious adverse events(Up to week 12 and week 24)
- Time to target diabetic foot ulcer re-occurrence(Up to 24 weeks)
- Time to amputation(Up to 24 weeks)
- Pain assessment(Week 1, Week 8, Week 12, Week 24)
- Quality of life survey(Week 1, Week 8, Week 12, Week 24)