Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb.
Currently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men or women > 30 years old
- •Subject is able and willing to comply with study procedures, and is able to give signed and dated consent
- •Subject meets criteria for diagnosis of Diabetes Mellitus Type 1 or 2, active Charcot neuroarthropathy, and peripheral neuropathy
- •Subjects with serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0mg/dL)
排除标准
- •Unable to provide signed and dated consent.
- •Charcot neuroarthropathy of the ipsilateral lower extremity, diagnosed over 1 month prior.
- •Prior foot or ankle surgery of the ipsilateral lower extremity.
- •Prior amputation at any level of either lower extremity.
- •Prior foot or ankle fracture of the ipsilateral lower extremity unrelated to the current acute CN episode.
- •Currently has any of the following:
- •Foot ulceration
- •Hypocalcemia
- •Creatinine clearance less than 30 mL/min or on dialysis
- •Pre-existing disturbance of mineral metabolism (e.g., hypoparathyroidism unstable on therapy, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine, history of diseases affecting bone metabolism) that has not been effectively corrected or treated.
- •Have undergone revascularization procedures of the lower extremities.
- •Female subjects who are pregnant or planning to breastfeed should not participate in this study.
- •Determined to have poor oral hygiene after dental screening or are at increased risk for developing osteonecrosis of the jaw.
- •History of osteonecrosis of the jaw.
- •History of tooth extraction or other dental surgery within the prior 6 months.
- •Invasive dental work planned in the next 2 years.
- •Have a known hypersensitivity to Prolia.
- •Known use of a bone active medication within the 6 months prior to enrollment.
- •Liver disease, defined as AST > 2.0x ULN, ALT > 2.0x ULN, TBL > 1.5x ULN.
- •Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
研究组 & 干预措施
Intervention Group, receiving medication
Subjects in this group will be receiving medication (denosumab)
干预措施: Denosumab (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 1 year
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
次要结局
- Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.(6 months)