A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety as determined by number of participants with post-surgical reactions
研究概览
简要总结
This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.
详细描述
Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography.
Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure.
Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between the ages of 18-75 years
- •Have clinical indications for whole sural nerve biopsy
- •Have a sural nerve SNAP with amplitude > or = 2 microvolt (μV)
- •Are able to comply with protocol requirements
- •Can provide written informed consent
- •Willingness to complete study procedures
排除标准
- •Current smoker.
- •History of prior musculoskeletal (joint or soft tissue) infection.
- •Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
- •Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
- •Have diabetes mellitus.
- •Have previous trauma to the biopsy site.
- •Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
- •Are pregnant or breast-feeding.
- •Unwilling to use adequate contraception.
研究组 & 干预措施
Biopsy + Nerve Repair
Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.
干预措施: Biopsy + Nerve Repair (Device)
Biopsy Only
Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.
干预措施: Biopsy Only (Procedure)
结局指标
主要结局
Safety as determined by number of participants with post-surgical reactions
时间窗: up to 5 years post surgery
Post-surgical reactions will include evaluations of the following: 1. Percussion tenderness at site of proximal stump or repair site; 2. Skin redness at the site of biopsy (length and width measured with calipers); 3. Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4. 4. Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.
次要结局
- Neuroma formation(3 months & 12 months)
- Neuropathic pain as measured by visual analogue pain scale(weekly, monthly for first 3 months, then 12 months and yearly for 4 years)
- Neuropathic pain as measured by SNAP(3 months & 12 months)
- Sensory nerve regeneration as measured by ultrasound(3 months & 12 months)
- Neuropathic pain as measured by visual analogue pain assessment questionnaire(weekly, monthly for first 3 months, then 12 months and yearly for 4 years)
- Sensory nerve regeneration as measured by SNAP(3 months & 12 months)
研究者
Anthony J. Windebank
Professor of Neurology
Mayo Clinic