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

Ain Shams University

Status

Active, not recruiting

Conditions

Diabetic Foot

Chronic Limb-Threatening Ischemia

Vascular Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT06542523

AinShamsUnivascular

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diabetic foot in the form of gangrene, or a lower limb ulceration >2 weeks duration.

Exclusion criteria

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