Chronic Limb-Threatening IschemiaNCT06209866
The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage
An observational study of Chronic Limb-Threatening Ischemia, run by Assiut University.
Trial summary
compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- PTA
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at vascular surgery department of Assiut university
Who may be able to join
- -
- Patients with CLTI who will undergo endovascular revascularization at our department:
- Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)
Who cannot join
- Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia
- Post Traumatic Ischemia
- Chronic ischemia caused by connective tissue diseases or vasculitis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role Of Global Limb Anatomic Staging System ( GLASS) Compared to Wound, Ischemia, Foot Infection Stage ( WIFI) in Predicting Limb Salvage After Endovascular Revascularization Procedures in Chronic Limb Threatening Ischemia Patients
compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.
Read the detailed description
Peripheral arterial disease (PAD) is estimated to affect over 200 million people worldwide. These rates are expected to rise as increasing life expectancies continue to shift the population toward older age. At the most severe end of the disease spectrum, chronic limb-threatening ischemia (CLTI) affects 11% of patients with PAD and is associated with high rates of limb loss and mortality as well as high costs of care.(1) The Society for Vascular Surgery's WIfI (Wound, Ischemia, foot Infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . These include the extent of the wound, degree of ischemia, and severity of any foot infection. It has been validated as a predictor of limb salvage in peripheral artery disease.(2,3)
The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. But it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (CLTI).
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- PTA
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTADevice
Percutaneous Trans lumenal Angioplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
in - line arterial flow to the foot without any flow limiting dissection or residual stenosis > 30% on completion intraoperative arteriography
Measured: Baseline
Time to complete healing
Time to complete healing of the wound after revascularization, Debridement or minor amputation
Measured: Baseline
Limb Salvage
freedom from major amputation above the foot level
Measured: Baseline
Primary Patency
uninterrupted vessel patency with no procedure performed on the treated limb.
Measured: Baseline
Assisted Primary Patency
the percentage of failing but still patent vessel undergoing elective intervention, included patients required revision of the revascularization before vessel occlusion occurs as prophylactic interventions to maintain patency.
Measured: Baseline
Secondary Patency
an occluded artery that required intervention to restore patency.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Bashandi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209866
- Sponsor's protocol ID
- Glass Stage and WIFI Stage
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, Zakharyan A, Hirsch AT. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014 Sep;60(3):686-95.e2. doi: 10.1016/j.jvs.2014.03.290. Epub 2014 May 10.
PubMed 24820900Ananthakumar Murugavel, Ajay Savlania, Arunanshu Behera,Mandeep Kang, Comparison of GLASS Stage with WIfI Clinical Staging for Predicting Limb Salvage in Peripheral Arterial Disease.j.jvs.2023.01.104
Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.
PubMed 31182334Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
PubMed 24126108
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Global Limb Anatomic Staging System ( GLASS) Compared to Wound, Ischemia, Foot Infection Stage ( WIFI) in Predicting Limb Salvage After Endovascular Revascularization Procedures in Chronic Limb Threatening Ischemia Patients
- ClinicalTrials.gov ID
- NCT06209866
- Acronym / sponsor ID
- Glass Stage and WIFI Stage
- Conditions
- Chronic Limb-Threatening Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Jan 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.
compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.
Detailed description
Peripheral arterial disease (PAD) is estimated to affect over 200 million people worldwide. These rates are expected to rise as increasing life expectancies continue to shift the population toward older age. At the most severe end of the disease spectrum, chronic limb-threatening ischemia (CLTI) affects 11% of patients with PAD and is associated with high rates of limb loss and mortality as well as high costs of care.(1) The Society for Vascular Surgery's WIfI (Wound, Ischemia, foot Infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . These include the extent of the wound, degree of ischemia, and severity of any foot infection. It has been validated as a predictor of limb salvage in peripheral artery disease.(2,3)
The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. But it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (CLTI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at vascular surgery department of Assiut university
Key inclusion criteria (3 listed)
- -
- Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)
Key exclusion criteria (3 listed)
- Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTAPercutaneous Trans lumenal Angioplasty | Device | – |
Primary outcome
Technical Success
Time frame: Baseline
in - line arterial flow to the foot without any flow limiting dissection or residual stenosis > 30% on completion intraoperative arteriography
Time to complete healing
Time frame: Baseline
Time to complete healing of the wound after revascularization, Debridement or minor amputation
Limb Salvage
Time frame: Baseline
freedom from major amputation above the foot level
Primary Patency
Time frame: Baseline
uninterrupted vessel patency with no procedure performed on the treated limb.
Assisted Primary Patency
Time frame: Baseline
the percentage of failing but still patent vessel undergoing elective intervention, included patients required revision of the revascularization before vessel occlusion occurs as prophylactic interventions to maintain patency.
Secondary Patency
Time frame: Baseline
an occluded artery that required intervention to restore patency.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 24820900Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, Zakharyan A, Hirsch AT. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014 Sep;60(3):686-95.e2. doi: 10.1016/j.jvs.2014.03.290. Epub 2014 May 10.
- BackgroundAnanthakumar Murugavel, Ajay Savlania, Arunanshu Behera,Mandeep Kang, Comparison of GLASS Stage with WIfI Clinical Staging for Predicting Limb Salvage in Peripheral Arterial Disease.j.jvs.2023.01.104
- Background: PubMed 31182334Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.
- Background: PubMed 24126108Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Limb-Threatening Ischemia, run by Assiut University.
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 3 inclusion and 3 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Ahmed Mohamed, Resident (01028524010, mohamedbashandy20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209866, which also lists 4 linked publications.
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 23 Jan 2024.