A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Individual patient success and findings at the 8 week follow-up visit
研究概览
简要总结
The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.
详细描述
The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.
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
- 否
入选标准
- •In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- •Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure.
- •Operative candidate for flap surgery or primary closure.
- •Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.
- •Adults ≥ 18 years in age at the time of treatment.
- •Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
- •Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.
- •Subjects who meet any of the following criteria will be excluded from participating in this study:
- •Reasons contributing to pressure ulcer cannot be addressed.
- •Severe immunological compromised patients as determined by the clinician.
- •Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.
- •Patients presenting with head pressure ulcers.
- •Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures.
- •Current smoker.
- •Diabetic patient with Hba1C level above
- •Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).
- •Concurrent involvement in a study of another investigational product.
- •Pregnant or planning to become pregnant during study period.
- •Flexion contractures where patient cannot passively get full extension.
- •Uncontrolled muscle spasms.
- •Unable to comply with bedrest restriction or offloading requirements
- •Unable to provide consent.
- •Fecal or urinary incontinence with contamination of the wound.
- •Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg *
- •Investigator considers the participant to be clinically malnourished.
- •Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).
- •Investigator believes trial participation may compromise safety of the participant or trial results.
- •Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization
排除标准
- 未提供
研究组 & 干预措施
Interventional STIMULAN VG
Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity.
Flap/primary closure. Peri-operative antibiotics.
干预措施: Standard of Care (Procedure)
Standard of Care (SoC)
Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
干预措施: Standard of Care (Procedure)
Interventional STIMULAN VG
Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity.
Flap/primary closure. Peri-operative antibiotics.
干预措施: STIMULAN VG (Combination Product)
结局指标
主要结局
Individual patient success and findings at the 8 week follow-up visit
时间窗: 8 week
An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.
次要结局
未报告次要终点