NCT06598241招募中不适用
A Pilot, Post-market, Non-interventional, Prospective, Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix (BBGFM) in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis.
The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Complete Wound Closure
研究概览
简要总结
This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.
详细描述
While participants are taking part in this study, they will be asked to attend approximately 12 weekly visits, or until the ulcer has healed. After the ulcer has healed there will be two follow up visits for confirmation, these visits are two weeks apart. Visits with the researchers and/or study staff will last for 16 weeks or less. Participants will continue and complete regular follow-up visit with their treating doctor while participating in this study.
The purpose of this study is to collect information about the product safety and efficacy of real-world scenarios on treating diabetic foot ulcers. The data that will be collected will help understand long-term risk and benefit from a real-world population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The subject has signed the informed consent form
- •Subject is male or female aged between ≥ 18 or ≤ 80
- •Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer
- •Index ulcer has not received an application of BBFGM previously
- •Subjects with insurance coverage for BBGFM
- •Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.
- •The subject is under the care of Physician for the management of Diabetes Mellitus
- •Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot
- •Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2
- •Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM
- •The BBGFM will be applied in an outpatient setting
- •Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator
- •Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit
- •Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit
- •Wagner Grade 3 subjects must have osteomyelitis diagnosed by:
- •X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound
- •Subject does not require a surgical debridement in the operating room
- •Subjects without active cellulitis at the index ulcer
- •Subject or responsible caregiver is willing to comply with the dressing treatment and study visits
- •Subject is willing to utilize the offloading device to offload wound
- •If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.
- •Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:
- •A.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses
排除标准
- •Subject is unwilling to sign informed consent
- •Subjects who cannot obtain insurance coverage for BBFGM
- •The BBFGM cannot be applied in an outpatient setting
- •Index ulcer has previously received an application of BBFGM
- •Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation
- •Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application
- •Subject is pregnant or breast-feeding.
- •Subject index ulcer associated with carcinoma.
- •Subject has active Charcot Neuroarthropathy
- •Subject requires extensive soft tissue and bone debridement in the operating room
- •Subject has a life expectancy of less than six months as assessed by the investigator.
- •Subject not in reasonable metabolic control in the judgment of the investigator
- •Subject with a known history of poor compliance with medical treatments
- •Subject currently undergoing cancer treatment
- •Subject has been on oral steroid use of <7.5 mg daily for greater than seven consecutive days in 30 days before screening
- •Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening
- •The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening
- •Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.
- •Subject currently receiving radiation therapy or chemotherapy.
- •Patient currently on dialysis or planning to start dialysis.
- •Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- •Subject is unable to sustain off-loading as defined by the protocol
- •Subject index ulcer that cannot be offload by an offloading device
- •Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/or presence of acute cellulitis at the index ulcer
- •Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study
- •Subjects who are permanently non-ambulatory (i.e. wheelchair bound)
- •The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)
- •Subject has an allergy to primary or secondary dressing materials used in this trial
- •In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection
结局指标
主要结局
Complete Wound Closure
时间窗: Week 12
Number of patients to achieve complete wound closure. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
次要结局
- 60% Reduction in wound size(Baseline to 12 weeks)
- Pain level using Visual Analog Scale(Baseline to 12 weeks)
- Change in Lower Extremity Function Scale (LEFS )(Baseline to 12 weeks)
- Number of Adverse Events related to BBGFM(Baseline to 12 weeks)
- Number of subjects with either cellulitis, infection and/or osteomyelitis(Baseline to 12 weeks)
- Timing to achieve 100% granulation coverage of wound surface(Baseline to 12 weeks)
- Number of Applications to achieve 100% granulation coverage of wound surface(Baseline to 12 weeks)
- Hospitalization rate for wound related events(Baseline to 12 weeks)
- Number of Amputations(Baseline to 12 weeks)
研究者
研究点 (2)
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