Chronic Limb-Threatening IschemiaNCT06542523
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
An observational study of Chronic Limb-Threatening Ischemia and Diabetic Foot, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Limb-Threatening Ischemia, Diabetic Foot, Vascular Diseases
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients walking in or referred to the out-patient clinic at Ain Shams University Specialized Hospitals or El-Demerdash University Hospitals with symptoms of diabetic foot ulcer or gangrene.
Who may be able to join
- diabetic foot in the form of gangrene, or a lower limb ulceration >2 weeks duration.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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:
- 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.
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Diabetic Foot, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| WIFI stage 1 with type 1 foot arch | Not described | |
| WIFI stage 2 with type 1 foot arch | Not described | |
| WIFI stage 3 with type 1 foot arch | Not described | |
| WIFI stage 1 with type 2a foot arch | Not described | |
| WIFI stage 2 with type 2a foot arch | Not described | |
| WIFI stage 3 with type 2a foot arch | Not described | |
| WIFI stage 1 with type 2b foot arch | Not described | |
| WIFI stage 2 with type 2b foot arch | Not described | |
| WIFI stage 3 with type 2b foot arch | Not described | |
| WIFI stage 1 with type 3a foot arch | Not described | |
| WIFI stage 2 with type 3a foot arch | Not described | |
| WIFI stage 3 with type 3a foot arch | Not described | |
| WIFI stage 1 with type 3b foot arch | Not described | |
| WIFI stage 2 with type 3b foot arch | Not described | |
| WIFI stage 3 with type 3b foot arch | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Healing
Wound closure with the restoration of tissue integrity and absence of signs of infection.
Measured: 2,4,6 months
Partial Healing:
significant improvement but not complete closure; may involve change in wound size and improved tissue viability.
Measured: 2,4,6 months
Worsening
change in wound size or signs of infection which may necessitates performing major amputation. .
Measured: 2,4,6 months
Secondary outcomes (1)
Occurrence of Complication
Rates of procedure- and device-related adverse events during revasularization
Measured: within 30 days of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542523
- Sponsor's protocol ID
- AinShamsUnivascular
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06542523
- Acronym / sponsor ID
- AinShamsUnivascular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| WIFI stage 1 with type 1 foot arch | – | – |
| WIFI stage 2 with type 1 foot arch | – | – |
| WIFI stage 3 with type 1 foot arch | – | – |
| WIFI stage 1 with type 2a foot arch | – | – |
| WIFI stage 2 with type 2a foot arch | – | – |
| WIFI stage 3 with type 2a foot arch | – | – |
| WIFI stage 1 with type 2b foot arch | – | – |
| WIFI stage 2 with type 2b foot arch | – | – |
| WIFI stage 3 with type 2b foot arch | – | – |
| WIFI stage 1 with type 3a foot arch | – | – |
| WIFI stage 2 with type 3a foot arch | – | – |
| WIFI stage 3 with type 3a foot arch | – | – |
| WIFI stage 1 with type 3b foot arch | – | – |
| WIFI stage 2 with type 3b foot arch | – | – |
| WIFI stage 3 with type 3b foot arch | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients walking in or referred to the out-patient clinic at Ain Shams University Specialized Hospitals or El-Demerdash University Hospitals with symptoms of diabetic foot ulcer or gangrene.
Key inclusion criteria (1 listed)
- diabetic foot in the form of gangrene, or a lower limb ulceration >2 weeks duration.
Key exclusion criteria (9 listed)
- Age below 18 years old.
- Critically ill patients
- Patients with acute ischemia
- patients with pure venous ulcer
- patients with ulcer due to rheumatological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete Healing
Time frame: 2,4,6 months
Wound closure with the restoration of tissue integrity and absence of signs of infection.
Partial Healing:
Time frame: 2,4,6 months
significant improvement but not complete closure; may involve change in wound size and improved tissue viability.
Worsening
Time frame: 2,4,6 months
change in wound size or signs of infection which may necessitates performing major amputation. .
1 secondary outcome
Occurrence of Complication
Time frame: within 30 days of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Limb-Threatening Ischemia and Diabetic Foot, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Healing (time frame: 2,4,6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.