Observational Study Regarding the Necessity of Inclusion of Foot Arch State Together With the Angiosome Theory Within the Wound, Ischemia and Foot Infection Classification (WIfI) to Enhance the Predictability of Wound Healing and Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete Healing
研究概览
简要总结
This study aims to assess the complete healing or healing progress of foot ulcer within 1 year Where the patients will be classified according to foot arch state together with the angiosome theory and the WIFI clinical stage to reflect the the necessity of inclusion of foot arch state together with the angiosome theory within the WIFI classification to enhance the predictability of wound healing and decision making
详细描述
Patients will be classified according to their WIFi stages into 3 groups and each group will be furtherly classified according to the patient's angiography of foot arch (whether by CT angiography or direct angiography) into:
Type 1: patent foot arch Type 2: partially occluded foot arch which is divided into whether Type 2a: patent dorsal tributary of foot arch Type 2b: patent lateral tributary of foot arch Type 3: totally occluded foot arch is divided into whether. Type 3a: totally occluded foot arch with anterior tibial artery inflow. Type 3b: totally occluded foot arch with posterior tibial artery inflow.
During follow-up assessments, wound is classified to be within: anterior tibial artery, posterior tibial artery or both territories.
Wound healing states are often classified based on the progression of the healing process into each of the following categories such as:
- Complete Healing: Wound closure with the restoration of tissue integrity and absence of signs of infection.
- Partial Healing: Significant improvement but not complete closure; may involve reduction in wound size and improved tissue viability.
- Worsening: Increase in wound size or signs of infection which may necessitates performing major amputation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic foot in the form of gangrene, or a lower limb ulceration >2 weeks duration.
排除标准
- •Age below 18 years old.
- •Critically ill patients
- •Patients with acute ischemia
- •patients with pure venous ulcer
- •patients with ulcer due to rheumatological disease
- •The patient has known sensitivity to heparin.
- •The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
- •The patient has an untreatable allergy to radiographic contrast material.
- •Patient refusing consent
结局指标
主要结局
Complete Healing
时间窗: 2,4,6 months
Wound closure with the restoration of tissue integrity and absence of signs of infection.
Partial Healing:
时间窗: 2,4,6 months
significant improvement but not complete closure; may involve change in wound size and improved tissue viability.
Worsening
时间窗: 2,4,6 months
change in wound size or signs of infection which may necessitates performing major amputation. .
次要结局
- Occurrence of Complication(within 30 days of the procedure)