Lower Limb Ischemia CriticalNCT05570968
Outcomes of Endovascular Revascularization in CLTI in Patients Associated With Heel Ulcers
An observational study of Lower Limb Ischemia Critical, run by Assiut University.
Trial summary
The aim of the current study is to assess outcomes of endovascular revascularization of patients with CLTI associated with heel ulcers and identify possible predictors of healing of these ulcers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Limb Ischemia Critical
- What is being tested?
- C-arm device
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: All patients with chronic limb threatening ischemia associated with heel ulcers Males or Females
Who may be able to join
- Patients suffering from CLTI associated with heel ulcers who will undergo endovascular revascularization at Assiut university vascular surgery department between August 2022 and November 2023.
Who cannot join
- Patients with arterial thrombosis , dissection, or embolism.
- Known intolerance to the study medications or contrast agents
- Patients with failing or failed bypass grafts
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of Endovascular Revascularization in Patients With Chronic Limb Threatening Ischemia (CLTI) Associated With Heel Ulcers
The aim of the current study is to assess outcomes of endovascular revascularization of patients with CLTI associated with heel ulcers and identify possible predictors of healing of these ulcers.
Read the detailed description
Peripheral Arterial Disease (PAD) is a progressive disorder characterized by stenosis and/or occlusion of large and medium-sized arteries and affects the lower extremities more commonly than the upper extremity vessels, and may lead to a recurrent fatigue, cramping sensation, or pain that is known as intermittent claudication, which is the most recognized symptomatic subset of lower extremity PAD. (1) Chronic limb threatening ischemia (CLTI) is an advanced form of PAD encompassing rest pain, lower limb ulceration or gangrene. It is associated with significant morbidity, mortality and healthcare resource utilization. (2) The Society for Vascular Surgery (SVS) Lower Extremity Guidelines Committee realized there was a need for a classification system for threatened limbs that encompassed the full spectrum of disease, as all existing classification systems fell short in this regard. So, they created the WIfI (Wound, Ischemia, and foot Infection) Classification System to categorize these three major risk factors leading to amputation. (3) It contains the key limb status elements needed to gauge the severity of limb threat, which enables physicians to predict amputation risk more accurately. (4) Either surgical or endovascular revascularization is the mainstay of therapy for CLTI. The continuous advance in the field of vascular interventional radiology has facilitated angioplasty through the development of low-profile balloon catheters, various small calibre stents, steerable and hydrophilic guide wires, road map facilities, vasodilators, and antiplatelet medication. (5) Heel ulcers in patients with diabetes mellitus (DM) and PAD are hard to heal. Diabetic heel ulcer is a well-known, hard to-heal ulcer and is considered a major risk factor for lower extremity amputation. Presence of foot ischemia, peripheral neuropathy with external trauma, and foot deformities will further increase the risk of amputation, and it is therefore highly likely that a patient with a diabetic heel ulcer with ischemia will have a great benefit from revascularization, especially if together with adequate infection control. (6)
- Conditions
- Lower Limb Ischemia Critical
- Being tested
- C-arm device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-arm deviceProcedure or surgery
Percutaneous Transluminal Angioplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
residual diameter stenosis of less than 30% at the end of the procedure as demonstrated on completion angiography
Measured: 1 year
Procedural complications
according to the society of intervention radiology (SIR) criteria.
Measured: 1 year
Secondary outcomes (3)
Primary patency
freedom from clinically driven target lesion revascularization (CD-TLR) and restenosis (DUS peak systolic velocity ratio >2.5
Measured: 1 year
CD-TLR
any re-intervention at the target lesion(s) due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure baseline ABI
Measured: 1 year
Amputation free survival (AFS)
s time until a major (above-ankle) amputation of the index limb or death from any cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Ischemia CriticalStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehia Mohamed Mostafa Abdelhadi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570968
- Sponsor's protocol ID
- Endovascular revascularization
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butt T, Lilja E, Orneholm H, Apelqvist J, Gottsater A, Eneroth M, Acosta S. Amputation-Free Survival in Patients With Diabetes Mellitus and Peripheral Arterial Disease With Heel Ulcer: Open Versus Endovascular Surgery. Vasc Endovascular Surg. 2019 Feb;53(2):118-125. doi: 10.1177/1538574418813746. Epub 2018 Nov 22.
PubMed 30466379Linn YL, Chan SL, Soon SXY, Yap CJQ, Lim MNHH, Lee QWS, Chong TT, Tang TY. Heal or no heel: Outcomes of ischaemic heel ulcers following lower limb revascularization from a multi-ethnic Asian Cohort in Singapore. Int Wound J. 2020 Dec;17(6):2010-2018. doi: 10.1111/iwj.13493. Epub 2020 Aug 24.
PubMed 32840061
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Endovascular Revascularization in Patients With Chronic Limb Threatening Ischemia (CLTI) Associated With Heel Ulcers
- ClinicalTrials.gov ID
- NCT05570968
- Acronym / sponsor ID
- Endovascular revascularization
- Conditions
- Lower Limb Ischemia Critical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 7 Oct 2022 (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.
The aim of the current study is to assess outcomes of endovascular revascularization of patients with CLTI associated with heel ulcers and identify possible predictors of healing of these ulcers.
Detailed description
Peripheral Arterial Disease (PAD) is a progressive disorder characterized by stenosis and/or occlusion of large and medium-sized arteries and affects the lower extremities more commonly than the upper extremity vessels, and may lead to a recurrent fatigue, cramping sensation, or pain that is known as intermittent claudication, which is the most recognized symptomatic subset of lower extremity PAD. (1) Chronic limb threatening ischemia (CLTI) is an advanced form of PAD encompassing rest pain, lower limb ulceration or gangrene. It is associated with significant morbidity, mortality and healthcare resource utilization. (2) The Society for Vascular Surgery (SVS) Lower Extremity Guidelines Committee realized there was a need for a classification system for threatened limbs that encompassed the full spectrum of disease, as all existing classification systems fell short in this regard. So, they created the WIfI (Wound, Ischemia, and foot Infection) Classification System to categorize these three major risk factors leading to amputation. (3) It contains the key limb status elements needed to gauge the severity of limb threat, which enables physicians to predict amputation risk more accurately. (4) Either surgical or endovascular revascularization is the mainstay of therapy for CLTI. The continuous advance in the field of vascular interventional radiology has facilitated angioplasty through the development of low-profile balloon catheters, various small calibre stents, steerable and hydrophilic guide wires, road map facilities, vasodilators, and antiplatelet medication. (5) Heel ulcers in patients with diabetes mellitus (DM) and PAD are hard to heal. Diabetic heel ulcer is a well-known, hard to-heal ulcer and is considered a major risk factor for lower extremity amputation. Presence of foot ischemia, peripheral neuropathy with external trauma, and foot deformities will further increase the risk of amputation, and it is therefore highly likely that a patient with a diabetic heel ulcer with ischemia will have a great benefit from revascularization, especially if together with adequate infection control. (6)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic limb threatening ischemia associated with heel ulcers Males or Females
Key inclusion criteria (1 listed)
- Patients suffering from CLTI associated with heel ulcers who will undergo endovascular revascularization at Assiut university vascular surgery department between August 2022 and November 2023.
Key exclusion criteria (3 listed)
- Patients with arterial thrombosis , dissection, or embolism.
- Known intolerance to the study medications or contrast agents
- Patients with failing or failed bypass grafts
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 |
|---|---|---|
| C-arm devicePercutaneous Transluminal Angioplasty | Procedure or surgery | – |
Primary outcome
Treatment success
Time frame: 1 year
residual diameter stenosis of less than 30% at the end of the procedure as demonstrated on completion angiography
Procedural complications
Time frame: 1 year
according to the society of intervention radiology (SIR) criteria.
3 secondary outcomes
Primary patency
Time frame: 1 year
CD-TLR
Time frame: 1 year
Amputation free survival (AFS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 30466379Butt T, Lilja E, Orneholm H, Apelqvist J, Gottsater A, Eneroth M, Acosta S. Amputation-Free Survival in Patients With Diabetes Mellitus and Peripheral Arterial Disease With Heel Ulcer: Open Versus Endovascular Surgery. Vasc Endovascular Surg. 2019 Feb;53(2):118-125. doi: 10.1177/1538574418813746. Epub 2018 Nov 22.
- Background: PubMed 32840061Linn YL, Chan SL, Soon SXY, Yap CJQ, Lim MNHH, Lee QWS, Chong TT, Tang TY. Heal or no heel: Outcomes of ischaemic heel ulcers following lower limb revascularization from a multi-ethnic Asian Cohort in Singapore. Int Wound J. 2020 Dec;17(6):2010-2018. doi: 10.1111/iwj.13493. Epub 2020 Aug 24.
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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 Lower Limb Ischemia Critical, 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 1 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 7 Oct 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?
Contact Yehia Mohamed Abdelhadi, PHD (+201147571718, yehiamohamed96@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 1 year). The study lists 2 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 NCT05570968, which also lists 2 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 7 Oct 2022.