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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

C-myc Biomarker Study for Diabetic Foot Ulcers

NCT04591691

Diabetes Diabetic Foot Diabetic Foot Ulcer +1 more

COMPLETED

Wound Healing In Diabetes (WHy) Study

NCT01002521

Impaired Wound Healing Diabetes Mellitus

UNKNOWN

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

NCT04232631

Diabetic Foot Ulcer

RECRUITING

Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study

NCT00759889

Diabetic Foot Leg Ulcer Decubitus Ulcer

COMPLETED

Impaired Wound Healing in Diabetic Foot Ulceration

NCT00739323

Diabetes Mellitus Healthy Volunteers

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Limb-Threatening Ischemia Diabetic Foot Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.