Critical Ischemia of FootNCT05098548
Pedal Arch Revascularization in Patients With Chronic Limb Threatening Ischemia
An observational study of Critical Ischemia of Foot, run by Assiut University.
Trial summary
Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels . CLTI is an undesirable clinical consequence of peripheral arterial disease (PAD) . Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Critical Ischemia of Foot
- What is being tested?
- angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The calculation was done using confidence interval 98 % giving a total sample size 28. According to the equation for sample size for prospective study design, prevalence of chronic limb threatening ischemia was 1.3 % of total population attending the Vascular Surgery Department [2]. Raising the sample size will be done up to 35 to compensate for dropout and refusal.
Who may be able to join
- All patients with Chronic limb threatening ischemia present with one or more of the following:
- Rest pain (Rutherford category 4)
- Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.
Who cannot join
- Patients presented with proved vasculitis.
- Patients with Chronic liver disease if there is prolonged PT.
- Patients with Heart failure if the patient is orthopneic and cannot lay on table for long time).
- Patients with impaired renal function.
About this study
Official title: Impact of Pedal Arch Patency on Outcomes of Endovascular Revascularization Procedures in Patients With Chronic Limb Threatening Ischemia
Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels . CLTI is an undesirable clinical consequence of peripheral arterial disease (PAD) . It affected ∼8 million people in the USA and affects 12-20% of American people aged more than 65 years. Within 1 year of diagnosis, 25% of those patients progress to a major amputation and the other 25% die due to co-morbid conditions
Read the detailed description
Revascularization is the cornerstone of Chronic limb threatening ischemia (CLTI) treatment for lower limb preservation . Endovascular revascularization is the favored approach in many centers because of its lower morbidity and mortality than open surgery . In a subset of patients with Chronic limb threatening ischemia, particularly in longstanding type 1 diabetic patients, a predominance of disease involving the pedal vessels can exist with relative sparing of the tibial vessels .The pedal arch describes the connection between the anterior and posterior circulation in the foot, this typically runs from the lateral plantar artery into the dorsalis pedis and represents the final arcade of outflow for the lower extremity vasculature . Secondary or "deep" pedal plantar loops connecting the medial and lateral tarsal arteries to the medial and lateral plantar arteries can also exist . A strong understanding of the pedal arch anatomy and its multiple connections is important for the physician performing not only pedal arch interventions, but tibial interventions as well . Familiarity with the arch anatomy increases procedural success rates in tibial intervention, as it gives the operator another collateral pathway to approach the target occlusion in a retrograde fashion . An intact pedal arch has been associated with improved wound healing, as well as a higher patency rate for bypass grafting and percutaneous interventions for inflow disease . An Angio some-directed revascularization strategy, however, has clearly been shown to improve wound healing and limb salvage rates in both surgical and endovascular series . Pedal arch intervention should therefore be considered in patients with advanced tissue loss, with a goal of restoring inline flow to the corresponding angiosomes, this could mean the difference between a major and minor amputation, as the options for these patients are limited and major amputation rates are high .
- Conditions
- Critical Ischemia of Foot
- Being tested
- angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplastyProcedure or surgery
using a balloon to stretch open a narrowed or blocked artery. However, most modern angioplasty procedures also involve inserting a short wire-mesh tube, called a stent, into the artery during the procedure. The stent is left in place permanently to allow blood to flow more freely .
| Study group | Role | What they receive |
|---|---|---|
| patients with Chronic limb threatening ischemia | All patients with Chronic limb threatening ischemia present with one or more of the following:
1. Rest pain (Rutherford category 4)
2. Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent. Receives: Procedure: angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of the vessel
Primary patency Which means maintaining vessel patency without restenosis or need for re-intervention .
Measured: From December 2021 to April 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Ischemia of FootStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Moustafa Farouk, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098548
- Sponsor's protocol ID
- PARIPWCLTI
- Status last verified
- Apr 2022
- First submitted
- 16 Oct 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pedal Arch Patency on Outcomes of Endovascular Revascularization Procedures in Patients With Chronic Limb Threatening Ischemia
- ClinicalTrials.gov ID
- NCT05098548
- Acronym / sponsor ID
- PARIPWCLTI
- Conditions
- Critical Ischemia of Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Oct 2021 (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.
Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels . CLTI is an undesirable clinical consequence of peripheral arterial disease (PAD) . It affected ∼8 million people in the USA and affects 12-20% of American people aged more than 65 years. Within 1 year of diagnosis, 25% of those patients progress to a major amputation and the other 25% die due to co-morbid conditions
Detailed description
Revascularization is the cornerstone of Chronic limb threatening ischemia (CLTI) treatment for lower limb preservation . Endovascular revascularization is the favored approach in many centers because of its lower morbidity and mortality than open surgery . In a subset of patients with Chronic limb threatening ischemia, particularly in longstanding type 1 diabetic patients, a predominance of disease involving the pedal vessels can exist with relative sparing of the tibial vessels .The pedal arch describes the connection between the anterior and posterior circulation in the foot, this typically runs from the lateral plantar artery into the dorsalis pedis and represents the final arcade of outflow for the lower extremity vasculature . Secondary or "deep" pedal plantar loops connecting the medial and lateral tarsal arteries to the medial and lateral plantar arteries can also exist . A strong understanding of the pedal arch anatomy and its multiple connections is important for the physician performing not only pedal arch interventions, but tibial interventions as well . Familiarity with the arch anatomy increases procedural success rates in tibial intervention, as it gives the operator another collateral pathway to approach the target occlusion in a retrograde fashion . An intact pedal arch has been associated with improved wound healing, as well as a higher patency rate for bypass grafting and percutaneous interventions for inflow disease . An Angio some-directed revascularization strategy, however, has clearly been shown to improve wound healing and limb salvage rates in both surgical and endovascular series . Pedal arch intervention should therefore be considered in patients with advanced tissue loss, with a goal of restoring inline flow to the corresponding angiosomes, this could mean the difference between a major and minor amputation, as the options for these patients are limited and major amputation rates are high .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Chronic limb threatening ischemia | – | Procedure: angioplastyAll patients with Chronic limb threatening ischemia present with one or more of the following: 1. Rest pain (Rutherford category 4) 2. Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The calculation was done using confidence interval 98 % giving a total sample size 28. According to the equation for sample size for prospective study design, prevalence of chronic limb threatening ischemia was 1.3 % of total population attending the Vascular Surgery Department [2]. Raising the sample size will be done up to 35 to compensate for dropout and refusal.
Key inclusion criteria (3 listed)
- All patients with Chronic limb threatening ischemia present with one or more of the following:
- Rest pain (Rutherford category 4)
- Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.
Key exclusion criteria (4 listed)
- Patients presented with proved vasculitis.
- Patients with Chronic liver disease if there is prolonged PT.
- Patients with Heart failure if the patient is orthopneic and cannot lay on table for long time).
- Patients with impaired renal function.
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 |
|---|---|---|
| angioplastyusing a balloon to stretch open a narrowed or blocked artery. However, most modern angioplasty procedures also involve inserting a short wire-mesh tube, called a stent, into the artery during the procedure. The stent is left in place permanently to allow blood to flow more freely . | Procedure or surgery | patients with Chronic limb threatening ischemia |
Primary outcome
Patency of the vessel
Time frame: From December 2021 to April 2022
Primary patency Which means maintaining vessel patency without restenosis or need for re-intervention .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Critical Ischemia of Foot
Enrolling by invitationObservational study
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Ischemia of Foot, 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 4 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 28 Apr 2022. 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?
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?
Patency of the vessel (time frame: From December 2021 to April 2022). 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 28 Apr 2022.