Chronic Limb-Threatening IschemiaNCT07488637
Woundsome Revascularization in Chronic Limb-Threatening Ischemia
A study testing Revascularization by Percutaneous Transluminal Angioplasty in people with Chronic Limb-Threatening Ischemia, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- Revascularization by Percutaneous Transluminal Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with chronic limb-threatening ischemia (CLTI) with tissue loss (Rutherford Class 5 or 6, or WIFI stage 2-4) 2. Patients with infrapopliteal arterial occlusions requiring revascularization
- -
Who cannot join
- Patients with unsalvageable limbs
- Patients with acute limb ischemia (ALI)
- Patients with non-atherosclerotic diseases such as vasculitis, including:
- Large vessel vasculitis (e.g., giant cell arteritis, Takayasu arteritis) Medium vessel vasculitis (e.g., polyarteritis nodosa, Kawasaki disease) Small vessel vasculitis (e.g., granulomatosis with polyangiitis, microscopic polyangiitis) Other types (e.g., Behçet's disease, Buerger's disease)
- Patients with contraindications to contrast medium
- Patients with aortoiliac or femoropopliteal occlusive disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Vascular and Endovascular surgery department Assiut university
Asyut, Asyut Governorate, 71511
Andrew Wageeh Resident doctor, Master's degree, +201149193361, andrewwageeh49@gmail.com
About this study
Official title: Impact of Woundsome Revascularization on the Outcomes of Endovascular Intervention in Patients With Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations, collateral circulation, and wounds involving multiple territories. The emerging "woundsome" concept focuses instead on improving arterial perfusion directly to the wound area, recognizing that both direct revascularization and
Read the detailed description
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of lower-extremity peripheral artery disease and is a major global health concern with increasing prevalence and significant health-care costs. Technological advancements, evolving revascularization strategies, and improved surgical and endovascular expertise have reduced the number of patients considered unsuitable for revascularization. Recent vascular guidelines acknowledge limitations in incorporating terminal circulation into treatment algorithms.
The angiosome concept describes six angiosomes in the foot and ankle supplied by the three main infrapopliteal arteries and was proposed as a method to guide revascularization and ensure direct blood flow to affected tissues. However, its utility is limited by variations in anatomy, the presence of collateral circulation, and the contribution of vessels such as branches of the peroneal artery. The condition of the pedal arch also plays an important role.
Additionally, larger wounds often involve more than one angiosome, which complicates the application of this concept. The "woundsome" concept has therefore emerged, emphasizing targeted improvement of arterial blood flow directly to the wound area in patients with CLTI and tissue loss. Evidence suggests that direct arterial perfusion to the wound is associated with better outcomes in limb salvage and wound healing. At the same time, the presence and quality of collateral circulation following indirect revascularization can also significantly influence clinical success and may provide outcomes comparable to direct revascularization.
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- Revascularization by Percutaneous Transluminal Angioplasty
- 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.
Revascularization by Percutaneous Transluminal AngioplastyProcedure or surgery
Endovascular revascularization is performed under fluoroscopic guidance using femoral artery access. Balloon angioplasty targets infrapopliteal vessels supplying direct blood flow to the wound. Post-procedure angiography assesses wound perfusion (woundsome), and patients are classified as having successful or unsuccessful woundsome revascularization based on contrast opacification around the wound.
| Study group | Role | What they receive |
|---|---|---|
| Woundsome-Guided Revascularization | Experimental | Revascularization strategy directed toward restoring arterial blood flow specifically to the wound location (woundsome). Target vessel selection is based on the artery most likely to provide direct perfusion to the wound area, considering anatomical variations, collateral circulation, and pedal arch patency, rather than relying solely on the traditional angiosome-based approach. Receives: Procedure: Revascularization by Percutaneous Transluminal Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Salvage
To assess the rate of limb salvage following woundsome-guided revascularization in patients with chronic limb-threatening ischemia.
Measured: Limb salvage will be assessed during follow-up for 12 months after woundsome revascularization. All patients will be scheduled for follow-up visits every 6 months for 1 year (0, 6, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Wageeh Latif, Assiut University
- Investigators
- Mahmoud Ismael Ahmed Saleh, PHD, Study director, Vascular and Endovascular surgery department Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488637
- Sponsor's protocol ID
- Woundsome_Revascularization
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Woundsome Revascularization on the Outcomes of Endovascular Intervention in Patients With Chronic Limb-Threatening Ischemia
- ClinicalTrials.gov ID
- NCT07488637
- Acronym / sponsor ID
- Woundsome_Revascularization
- Conditions
- Chronic Limb-Threatening Ischemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Mar 2026 (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 the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations, collateral circulation, and wounds involving multiple territories. The emerging "woundsome" concept focuses instead on improving arterial perfusion directly to the wound area, recognizing that both direct revascularization and
Detailed description
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of lower-extremity peripheral artery disease and is a major global health concern with increasing prevalence and significant health-care costs. Technological advancements, evolving revascularization strategies, and improved surgical and endovascular expertise have reduced the number of patients considered unsuitable for revascularization. Recent vascular guidelines acknowledge limitations in incorporating terminal circulation into treatment algorithms.
The angiosome concept describes six angiosomes in the foot and ankle supplied by the three main infrapopliteal arteries and was proposed as a method to guide revascularization and ensure direct blood flow to affected tissues. However, its utility is limited by variations in anatomy, the presence of collateral circulation, and the contribution of vessels such as branches of the peroneal artery. The condition of the pedal arch also plays an important role.
Additionally, larger wounds often involve more than one angiosome, which complicates the application of this concept. The "woundsome" concept has therefore emerged, emphasizing targeted improvement of arterial blood flow directly to the wound area in patients with CLTI and tissue loss. Evidence suggests that direct arterial perfusion to the wound is associated with better outcomes in limb salvage and wound healing. At the same time, the presence and quality of collateral circulation following indirect revascularization can also significantly influence clinical success and may provide outcomes comparable to direct revascularization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woundsome-Guided Revascularization | Experimental | Procedure: Revascularization by Percutaneous Transluminal AngioplastyRevascularization strategy directed toward restoring arterial blood flow specifically to the wound location (woundsome). Target vessel selection is based on the artery most likely to provide direct perfusion to the wound area, considering anatomical variations, collateral circulation, and pedal arch patency, rather than relying solely on the traditional angiosome-based approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients with chronic limb-threatening ischemia (CLTI) with tissue loss (Rutherford Class 5 or 6, or WIFI stage 2-4) 2. Patients with infrapopliteal arterial occlusions requiring revascularization
- -
Key exclusion criteria (6 listed)
- Patients with unsalvageable limbs
- Patients with acute limb ischemia (ALI)
- Patients with non-atherosclerotic diseases such as vasculitis, including:
- Large vessel vasculitis (e.g., giant cell arteritis, Takayasu arteritis) Medium vessel vasculitis (e.g., polyarteritis nodosa, Kawasaki disease) Small vessel vasculitis (e.g., granulomatosis with polyangiitis, microscopic polyangiitis) Other types (e.g., Behçet's disease, Buerger's disease)
- Patients with contraindications to contrast medium
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 |
|---|---|---|
| Revascularization by Percutaneous Transluminal AngioplastyEndovascular revascularization is performed under fluoroscopic guidance using femoral artery access. Balloon angioplasty targets infrapopliteal vessels supplying direct blood flow to the wound. Post-procedure angiography assesses wound perfusion (woundsome), and patients are classified as having successful or unsuccessful woundsome revascularization based on contrast opacification around the wound. | Procedure or surgery | Woundsome-Guided Revascularization |
Primary outcome
Limb Salvage
Time frame: Limb salvage will be assessed during follow-up for 12 months after woundsome revascularization. All patients will be scheduled for follow-up visits every 6 months for 1 year (0, 6, 12 months)
To assess the rate of limb salvage following woundsome-guided revascularization in patients with chronic limb-threatening ischemia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Vessel Recoil in Specific CLTI Populations
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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.
Mahmoud Ismael Ahmed Saleh, PHD study director
Vascular and Endovascular surgery department Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization by Percutaneous Transluminal Angioplasty in people with Chronic Limb-Threatening Ischemia, run by Assiut 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Wageeh Latif Resident Doctor, Master's degree (+201149193361, andrewwageeh49@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Salvage (time frame: Limb salvage will be assessed during follow-up for 12 months after woundsome revascularization. All patients will be scheduled for follow-up visits every 6 months for 1 year (0, 6, 12 months)). 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 1 Apr 2026.