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

Active, not recruiting

• Conditions: Chronic Limb-Threatening Ischemia; Vascular Diseases; Diabetic Foot

• Registration Number: NCT06542523
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed 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:

1. Complete Healing: Wound closure with the restoration of tissue integrity and absence of signs of infection.

2. Partial Healing: Significant improvement but not complete closure; may involve reduction in wound size and improved tissue viability.

3. Worsening: Increase in wound size or signs of infection which may necessitates performing major amputation.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-03-01
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

1. Age below 18 years old.
2. Critically ill patients
3. Patients with acute ischemia
4. patients with pure venous ulcer
5. patients with ulcer due to rheumatological disease
6. The patient has known sensitivity to heparin.
7. The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
8. The patient has an untreatable allergy to radiographic contrast material.
9. Patient refusing consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Healing	2,4,6 months	Wound closure with the restoration of tissue integrity and absence of signs of infection.
Partial Healing:	2,4,6 months	significant improvement but not complete closure; may involve change in wound size and improved tissue viability.
Worsening	2,4,6 months	change in wound size or signs of infection which may necessitates performing major amputation. .

Secondary Outcome Measures

Name	Time	Method
Occurrence of Complication	within 30 days of the procedure	Rates of procedure- and device-related adverse events during revasularization

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt