Diabetes Foot Africa Region Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Proportion of Subjects Achieving Complete Wound Healing
研究概览
简要总结
D-FAR is to gather robust data on the clinical characteristics, management, and outcomes of patients with diabetic foot complications to enhance understanding, reduce complications, and improve patient care. This will include insights into the prevalence of risk factors, adherence to treatment protocols, and the effectiveness of interventions aimed at reducing the incidence of amputations and other adverse outcomes.
详细描述
Among the various complications, those related to diabetic foot disease are associated with the highest morbidity and mortality. Diabetic foot problems are characterized by infection, ulceration and/or destruction of deep tissue in the foot and are usually associated with neurological abnormalities and varying degrees of peripheral arterial disease (PAD) in the lower limb. the purpose of collect comprehensive data on the clinical features, management strategies, and outcomes of patients with diabetic foot complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Residents of participating African countries.
- •Diagnosed with diabetic foot complications (e.g., ulcers, gangrene, infection, ischemia).
- •Patients with a history of foot ulcers or amputations due to diabetes.
- •High-risk patients with peripheral neuropathy and/or peripheral arterial disease.
排除标准
- •Non-diabetic foot complications.
- •Acute traumatic injuries unrelated to diabetes.
- •Patients unwilling to provide informed consent.
结局指标
主要结局
Proportion of Subjects Achieving Complete Wound Healing
时间窗: Assessed at 3, 6, and 12 months post-enrollment
Percentage of patients with diabetic foot ulcers who achieve complete wound closure without discharge or infection as recorded during follow-up visits. Defined as complete epithelialization of the diabetic foot ulcer with no discharge or infection as assessed during clinical follow-up.
Proportion of Subjects Undergoing Amputation Due to Diabetic Foot Ulcer
时间窗: Up to 12 months from enrollment
Number of subjects requiring surgical amputation (minor or major) of the affected foot during the follow-up period
次要结局
- Time Taken for Diabetic Foot Ulcer to Heal(Up to 12 months from enrollment)
- Change in SINBAD Score Over Time(Baseline, 3, 6, and 12 months)
- All-Cause Mortality Among Subjects with Diabetic Foot Ulcers(Up to 12 months from enrollment)
- Proportion of Subjects with Peripheral Neuropathy and Peripheral Arterial Disease(At baseline)