A Multi-center, Randomized, Controlled Feasibility Trial of STIMULAN VG and Debridement With an Abbreviated Course of Systemic Antibiotics to Debridement and a Full Course of Systemic Antibiotics for the Treatment of Diabetic Foot Osteomyelitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 10
- 主要终点
- Number of participants with no clinical need for further antibiotic therapy for infection at the index site
研究概览
简要总结
The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
详细描述
This trial is an open-label, multi-center, randomized, controlled feasibility trial.
All participants will undergo surgical debridement and receive either STIMULAN VG and an abbreviated course of systemic antibiotic therapy (3 days ±2 days) or a full course (4-6 weeks) of systemic antibiotic therapy.
The total duration of study is Approximately 55 weeks.
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
- •Participants are eligible to be included in the trial only if all of the following criteria apply:
- •Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
- •Participant has a current diagnosis and is being treated for diabetes mellitus, type 1 or type 2
- •Participant who has confirmed presence of DFO (to include all bones below the ankle including the talus and calcaneum) as evidenced by at least 3 out of 5 of the following:
- •Positive PTB test
- •Presence of draining sinus presumed to be from underlying bone
- •Plain X-ray or MRI scan highly suggestive of or most compatible with osteomyelitis
- •Ulcer present for greater than 30 days
- •Substantially elevated serum marker for inflammation (e.g. ESR >70 mm/hr and C-reactive protein >14mg/L or at least 40% higher than upper limits of normal value used at the investigational site)
- •Participant who requires surgical debridement OR Participant requiring amputation and/or resection where residual osteomyelitis remains that necessitates further surgical debridement
- •All genders are eligible to participate if they are not pregnant, not breastfeeding, are not of childbearing potential or they agree to follow contraceptive guidance
- •Subject or legal authorized representative able to provide, voluntary, signed and dated informed consent prior to any study related procedures
- •Exclusion criteria:
- •Participants are excluded from the trial if any of the following criteria apply:
- •Osteomyelitis in any location other than the foot (i.e. excluding any bones located proximal to the foot)
- •Osteomyelitis of the distal phalanx (toe tip) of the great toe or lesser toes
- •Charcot foot or other deformities where the investigator believes adequate offloading is not possible
- •Severe diabetic foot infection (grade 4) in accordance to IDSA/IWGDF criteria (Appendix 6)
- •Moderate to severe reduction in renal function, defined as estimated glomerular filtration rate (eGFR) of < 30.0 ml/min/1.73 m2 (Formula for calculating eGFR: 2021 CKD-EPI Creatinine).
- •Significant peripheral arterial disease:
- •Ankle brachial index ≤ 0.7 mm Hg OR
- •toe pressure ≤ 40 mm Hg OR
- •transcutaneous oximetry ≤ 40 mm Hg
- •Hemoglobin A1c (HbA1c) > 12%
- •Contra-indication or inability to undergo an MRI scan
- •Malignancy that might affect trial interpretation of outcomes or the participant's ability to complete the trial
- •Participant who is severely immunocompromised or has received high dose corticosteroids (>10 mg prednisone (or corticosteroid equivalent) for more than 14 consecutive days within the 90 days prior to informed consent)
- •Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism)
- •Patients with active COVID-19 will be excluded from enrollment until they are able to undergo the surgical procedure
- •Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that, in the judgment of the investigator, may compromise the ability of the trial participant to adhere to the trial conduct and procedures
- •Previous history of adverse incidents, allergy or contra indications (e.g. Myathesia Gravis) to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (vancomycin), or aminoglycoside antibiotics (gentamicin)
- •Concurrent involvement in a trial of another investigational product
- •The Investigator believes trial participation may compromise safety of the participant or the results of the trial
排除标准
- 未提供
研究组 & 干预措施
STIMULAN VG
Participants will receive STIMULAN VG on Day 1 following surgical debridement. Systemic antibiotics for 3 days ± 2 days following the debridement surgery.
干预措施: STIMULAN VG (Drug)
STIMULAN VG
Participants will receive STIMULAN VG on Day 1 following surgical debridement. Systemic antibiotics for 3 days ± 2 days following the debridement surgery.
干预措施: Systemic Antibiotics (Drug)
Standard of Care
Participants will receive Systemic antibiotics for 4-6 weeks following the debridement surgery.
干预措施: Systemic Antibiotics (Drug)
结局指标
主要结局
Number of participants with no clinical need for further antibiotic therapy for infection at the index site
时间窗: Week 24
Need for further antibiotic therapy for infection at the index site will be assessed at Week 24.
Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site
时间窗: Week 24
Confirmed absence of clinical signs of osteomyelitis or surgical site infection at the index site will be evidenced by Negative Probe to Bone Test (PTB), absence of draining sinus presumed to be from underlying bone and MRI scan at Week 24.
Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site
时间窗: Week 24
Need for further additional surgical procedure or debridement to treat infection at the index site will be assessed at Week 24.
次要结局
- Number of hospitalizations/re-hospitalizations as a result of treatment for osteomyelitis or ulceration at the index site(Week 52)
- Number of participants undergoing amputation at the index site(Week 52)
- Ulcer healing per the University of Texas (UT) Staging System for Diabetic Foot Ulcers(Week 12)
- Number of participants with occurrence of reinfection at the index site(Week 52)
- Number of participants with no clinical need for further antibiotic therapy for infection at the index site(Week 52)
- Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site(Week 52)
- Relative change from baseline in Cardiff Wound Impact Schedule (CWIS) quality of life assessment(Week 24)
- Number of participants with adverse events(Week 52)
- Number of participants discontinuing therapy prematurely due to a treatment related event(Week 52)
- Number of systemic antibiotic free days since trial surgery(Week 52)