Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542523
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None