Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Biological biochemical analysis
研究概览
简要总结
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.
详细描述
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.
A first population has no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); a second population is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.
One centre provides thorough biomechanical and functional analyses also based on modern Computed Tomography in weight-bearing; another centre performs state-of-the-art clinical assessments and metabolic analyses; the third centre performs the latter, together with advanced biological and biochemical analyses.
Comparisons of all these multi-instrumental measurements between the two populations are performed at baseline and at 12 month follow-up, with multidisciplinary investigative approach.
A mix of risk and predisposition factors should emerge combining the three groups of measures, in the two populations, along the two times of data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •for population 1:
- •Male and female patients aged between 18 and 75 years.
- •Diabetes mellitus type-2 patients with mild to moderate risk of ulceration at the foot (grade 2).
- •Inclusion Criteria for population 2:
- •Male and female patients aged between 18 and 75 years.
- •Patients with diabetes mellitus type-2 and diabetic foot with an history of ulcerative lesions (grade 3), healed for at least 6 months.
排除标准
- •for population 1:
- •History or evidence of ulcers at the foot
- •Infections in progress, ongoing neoplasms
- •Immunosuppressive therapies, and cortisone-based therapy
- •Pregnancy and lactation
- •Inability to provide informed consent
- •Exclusion Criteria for population 2:
- •Infections in progress, ongoing neoplasms
- •Immunosuppressive therapies, and cortisone-based therapy
- •Pregnancy and lactation
- •Inability to provide informed consent
研究组 & 干预措施
Population 1
Patients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk.
干预措施: Full Analysis (Procedure)
Population 2
Patients affected by diabetes mellitus type-2: typical adult subjects affected by diabetic foot, who had foot ulcers and thus in risk grade 3. The ulcerative lesions must have been resolved from at least 6 months, so that there is no longer acute inflammatory process in progress at the time of blood sampling.
干预措施: Partial Analysis (Procedure)
结局指标
主要结局
Biological biochemical analysis
时间窗: baseline, 12 months
Parameters related to the profile of blood biomarkers for inflammation will be acquired from samples collected for Population 1 and Population 2.
次要结局
- Clinical - metabolical analysis(baseline, 12 months)
- Functional analysis(baseline, 12 months)