A National, Prospective, Randomized, Multicenter, Controlled Comparison of Bioactive Glass S53P4 Versus Standard of Care Treatment of Diabetic Foot Osteomyelitis in the Forefoot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 14
- 主要终点
- healing rate
研究概览
简要总结
The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.
Participants will randomized into two groups:
- Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
- Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
详细描述
Patient with a diagnosis of ostemileytis localised in the forefoot will be randomized into two groups.
- Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
- Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
In any case a primary intent closure is pursued, both in Group A and B, a vacuum percutaneous drainage would be placed before closing the wound and removed in 2nd post-operative day, if necessary, by the surgeon.
Systemic antibiotic therapy will be started immediately on empirical basis, as per normal practice.
After the removal of drainage, or after the first post-operative control in 2nd post-operative day, as done routinely at study sites, patients will be evaluated biweekly either if they are still admitted or if they were dismissed and will be followed up by investigators blinded toward the groups.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Male or female patients >= of 18 years old.
- •They should have type I since at least 5 years or type II DM
- •They should have a diagnosis - confirmed by imaging and culture - of OM localized in the forefoot not responding for at least 2 up to 6 weeks to systemic antibiotic therapy and/or associated with soft tissue infection, abscess, phlegmon, necrosis, and for which a surgical debridement is indicated.
- •They should have palpable pulses on TP or DP at the ankle in the affected limb, and/or ABPI >0.7 and <1.2 and /or TcPO2 at dorsum of the foot ≥36 mmHg.
- •They should be able to accomplish with the procedures and prescriptions indicated by the Study protocol, particularly with the offloading prescription, as well as they should be willing and able to attend and respect the program of control visits and medications.
- •Anatomical area: forefoot.
排除标准
- •They should not have metabolic decompensation as witnessed by HbA1c >109 mmol/mol (> 12%).
- •They should not have major amputation on the contra-lateral limb.
- •They should not have acute or chronic Charcot's foot in the affected foot.
- •They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment.
- •They should not be taking corticosteroids, bisphosphonates, immunosuppressants, and more in general any drug which might interfere with bone metabolism or tissue repair, in thejudgment of investigators.
- •They should not have ESRD in dialysis.
- •They should not be bedridden or not ambulating.
- •They should not have a life expectancy shorter than one year.
- •They should not be too ill to sustain a surgical procedure under loco-regional anesthesia.
- •They should not have severe disease which might interfere with the expected course of the disease and therapy.
- •Hypersensitivity to any product ingredient(s) or history of anaphylactic reactions.
- •Participation in another interventional studies within 45 days prior to the start of the present study.
- •Predictable poor compliance or inability to communicate well with the investigator.
结局指标
主要结局
healing rate
时间窗: 6-month
complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits.
次要结局
- Proportion of patients undergoing amputations(through study completion, an average of 1 year)
- Time back to walk(through study completion, an average of 1 year)
- Duration of antibiotic therapy(through study completion, an average of 1 year)
- Number of re-interventions because of the same lesion(through study completion, an average of 1 year)
- Characteristics of surgery(intra-operative)
- Length of surgery(intra-operative)
- Rate of recurrences(6-months and 12-month)
- Timing of re-interventions because of the same lesion(through study completion, an average of 1 year)
- Patients' Quality of Life(6-months and 12-month)