VascularNCT07762222
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
A study testing dedicated venous stenting and Dedicated venous stent / iliofemoral dedicated venous stenting in people with Vascular and DVT - Deep Vein Thrombosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vascular, DVT - Deep Vein Thrombosis, Post Thrombotic Syndrome
- What is being tested?
- dedicated venous stenting and Dedicated venous stent / iliofemoral dedicated venous stenting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2025to 1 Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic non-healing venous ulcer associated with iliofemoral post-thrombotic syndrome.
- CEAP clinical classification C6.
- Iliofemoral post-thrombotic venous obstruction confirmed by appropriate venous imaging.
- Age 18 years or older.
- Ability to provide informed consent.
Who cannot join
- Nonthrombotic iliac vein lesion (NIVL).
- Post-phlebitic femoropopliteal venous lesions with a patent iliac vein.
- CEAP clinical classification other than C6.
- Previous venous intervention.
- Active pathological ulcer unrelated to post-thrombotic venous disease.
- Life expectancy less than 2 years.
Show all 10Show fewer
- Pregnancy.
- Known allergy to contrast media.
- Contraindication to anesthesia.
- Refusal to participate or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Naglaa Fathy Naglaa Fathy contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams univeristy hospital
Cairo, 1181
Ain shams university Ain shams university hospitals, Egypt +20 2 24346344, iso@med.asu.edu.eg
About this study
Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually. Among these patients, 20% to 50% may develop post-thrombotic syndrome (PTS), with the likelihood varying based on the extent and location of the thrombus. Notably, despite receiving anticoagulation therapy, 5% to 10% of patients may progress to severe PTS, potentially leading to the development of venous ulcers (Afsha Aurshina, 2018). Chronic venous obstruction (CVO) refers to the impediment of venous flow, typically resulting from either partial or complete blockage of the venous system. This obstruction leads to diminished venous flow and elevated pressure within the affected veins. CVO serves as a broad descriptor for various conditions, including post-thrombotic syndrome (PTS) and nonthrombotic iliac vein lesions (NIVLs). PTS commonly arises as a complication of deep vein thrombosis (DVT), with estimates indicating that up to 50% of patients diagnosed with iliofemoral DVT will develop PTS within two years following their initial diagnosis. (Mohammad E. Barbati, 2024)
The study aims to know the outcomes of iliac vein stenting with dedicated venous stenting in the treatment of post-thrombotic syndrome venous ulcer.
Read more
Type of Study: Prospective single arm cohort study
- Study Setting: Ain Shams University hospitals
- Study Period: 2 years with 6 months follow up
- Sample Size: 20 patients.
- Study Population Patients presenting to the outpatient clinic at Ain Shams University Hospitals with venous ulcers.
- Study Tools
- 20 patients will be selected.
- Written informed consent.
- Full history taking, personal history , risk factors of DVT, presence of any medical illness , assessment of QOL based on CVIQ 20 - questionnaire, list of symptoms, sensations or types of discomfort that you may or may not be experiencing and which may make everyday life hard to bear to a greater or lesser extent.
- Clinical evaluation: based on revised Venous Clinical Severity Score rVCSS , Villalta score and CEAP classification . rVCSS includes 10 items, such as pain, varicose veins, oedema, skin pigmentation, inflammation, skin induration, number of active ulcers, ulcer size, duration of ulcer, and application of pressure therapy. Each item is scored from 0 to 3 according to the severity, and the total score is 30. A higher score indicates higher severity. And using villlata score It can be used to both diagnose and categories the severity of the condition. The Villalta score involves both the patient who grades the presence and severity (0-3 points) of five symptoms ( pain , cramps, heaviness, parasthesia and pruritus ) and and the physician who grades six clinical signs(Pre-tibial oedema, Hyper-pigmentation, Redness, Venous Ectasia, ain on calf compression, ulcers) (0-3 points) after examination of the lower limb. Also the clinical severity of the venous disease will be graded according to the clinical, etiological, anatomical, and pathophysiological (CEAP) scoring system, and assessment of venous ulcer assessment (by onset, course, duration, site, size, shape
Read the detailed description
Study Procedures and Interventions:
All participants will receive standardized venous ulcer care, including wound assessment, appropriate dressing according to the amount of exudate, and elastic compression using class II elastic stockings. Wound care will be provided twice weekly in the vascular surgery clinic by the study investigators. Debridement and wound culture with sensitivity testing will be performed when clinically indicated.
Participants assigned to the interventional treatment will undergo endovascular iliac venous recanalization and stenting. The ipsilateral great saphenous vein, popliteal vein, or femoral vein will be used as the preferred venous access according to the anatomical characteristics of each case. Procedures will be performed under ultrasound guidance.
After venous access, an antegrade venogram will be obtained to assess the venous anatomy and determine the location and extent of iliac venous obstruction. A guidewire will be advanced across the obstructed segment, followed by balloon venoplasty using an appropriately sized balloon. A dedicated self-expanding venous stent will then be deployed across the obstructed segment. Stent diameter will be selected according to the venous anatomy and vessel dimensions, with adequate post-dilatation when required. Completion venography will be performed to assess the final venous flow and stent position.
Following the procedure, venous access sites will be compressed with a sterile dressing. Antithrombotic treatment will be administered according to the study protocol. Low-molecular-weight heparin will be administered at a dose of 5000 IU every 12 hours after stent implantation, followed by therapeutic anticoagulation with warfarin targeting an international normalized ratio of 2-3 or rivaroxaban 20 mg once daily for at least 1 year after hospital discharge.
Postoperative Follow-up:
Clinical follow-up will be performed at 7 days, 1 month, 3 months, 6 months, and 12 months after treatment. Follow-up assessments will include venous ulcer healing, ulcer diameter and depth, time to complete healing, and changes in venous clinical severity and quality-of-life scores. Venous duplex ultrasound will be performed during follow-up to assess stent patency. Computed tomography venography will be performed in cases of suspected stent occlusion, recurrent symptoms, or recurrent venous ulceration.
- Being tested
- dedicated venous stenting, Dedicated venous stent / iliofemoral dedicated venous stenting
- Keywords
- iliofemoral postthrombotic syndrome, venous ulcer, dedicated iliac venous stenting
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dedicated venous stentingProcedure or surgery
Also called venoplasty
iliofemoral dedicated venous stenting
Dedicated venous stent / iliofemoral dedicated venous stentingDevice
Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy.
| Study group | Role | What they receive |
|---|---|---|
| Iliofemoral dedicated venous stenting | Experimental | Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy. Receives: Procedure: dedicated venous stenting; Device: Dedicated venous stent / iliofemoral dedicated venous stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete healing of venous ulcer
Proportion of participants with complete healing of the venous ulcer at 12 months after iliofemoral venous stenting.
Measured: 12 months
Secondary outcomes (3)
Time to complete venous ulcer healing
Time from venous stenting to complete healing of the venous ulcer, measured in days.
Measured: 12 months
Change in rVCSS
Change in revised Venous Clinical Severity Score (rVCSS) from baseline to 12 months after treatment.
Measured: 12 months
Venous ulcer recurrence
Proportion of participants with recurrence of a previously healed venous ulcer during the 12-month follow-up period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start2 Mar 2025
- Primary completion2 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for VascularStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- choronic non healing venous ulcer patients with post thrombotic syndrome with iliofemoral venous occlusion
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07762222
- Sponsor's protocol ID
- FMASU MD123/2025
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Share for MD
Publications
Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27.
PubMed 32113854Marston WA, Vasquez MA, Lurie F, Wakefield TW, Rabe E, Shortell CK, Lohr JM, Passman MA, McLafferty RB; American Venous Forum Outcomes Working Group. Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS). J Vasc Surg Venous Lymphat Disord. 2013 Jul;1(3):219-24. doi: 10.1016/j.jvsv.2012.10.059. Epub 2013 May 18.
PubMed 26992578Wang J, Smeath E, Lim HY, Nandurkar H, Kok HK, Ho P. Current challenges in the prevention and management of post-thrombotic syndrome-towards improved prevention. Int J Hematol. 2023 Nov;118(5):547-567. doi: 10.1007/s12185-023-03651-6. Epub 2023 Aug 31.
PubMed 37651058Pappas CP, Lakhanpal G, Kennedy R, Lakhanpal S, Shahi S, Pappas PJ. Outcomes of iliofemoral venous stenting in women with venous ulcers. J Vasc Surg Venous Lymphat Disord. 2026 Jul;14(4):102492. doi: 10.1016/j.jvsv.2026.102492. Epub 2026 Mar 30.
PubMed 41921606Jalaie H, Barbati ME, Piao L, Doganci S, Kucher N, Dumantepe M, Hartung O, Lichtenberg M, Black S, O'Sullivan G, Avgerinos ED, Davies AH, Razavi MK; International CVO Classification Study Group. Prognostic Value of a Classification System for Iliofemoral Stenting in Patients with Chronic Venous Obstruction. Eur J Vasc Endovasc Surg. 2025 Feb;69(2):315-322. doi: 10.1016/j.ejvs.2024.10.002. Epub 2024 Oct 10.
PubMed 39393577
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
- ClinicalTrials.gov ID
- NCT07762222
- Acronym / sponsor ID
- FMASU MD123/2025
- Keywords
- iliofemoral postthrombotic syndrome, venous ulcer, dedicated iliac venous stenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Aug 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.
Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually. Among these patients, 20% to 50% may develop post-thrombotic syndrome (PTS), with the likelihood varying based on the extent and location of the thrombus. Notably, despite receiving anticoagulation therapy, 5% to 10% of patients may progress to severe PTS, potentially leading to the development of venous ulcers (Afsha Aurshina, 2018). Chronic venous obstruction (CVO) refers to the impediment of venous flow, typically resulting from either partial or complete blockage of the venous system. This obstruction leads to diminished venous flow and elevated pressure within the affected veins. CVO serves as a broad descriptor for various conditions, including post-thrombotic syndrome (PTS) and nonthrombotic iliac vein lesions (NIVLs). PTS commonly arises as a complication of deep vein thrombosis (DVT), with estimates indicating that up to 50% of patients diagnosed with iliofemoral DVT will develop PTS within two years following their initial diagnosis. (Mohammad E. Barbati, 2024)
The study aims to know the outcomes of iliac vein stenting with dedicated venous stenting in the treatment of post-thrombotic syndrome venous ulcer.
Type of Study: Prospective single arm cohort study
- Study Setting: Ain Shams University hospitals
- Study Period: 2 years with 6 months follow up
- Sample Size: 20 patients.
- Study Population Patients presenting to the outpatient clinic at Ain Shams University Hospitals with venous ulcers.
- Study Tools
- 20 patients will be selected.
- Written informed consent.
- Full history taking, personal history , risk factors of DVT, presence of any medical illness , assessment of QOL based on CVIQ 20 - questionnaire, list of symptoms, sensations or types of discomfort that you may or may not be experiencing and which may make everyday life hard to bear to a greater or lesser extent.
- Clinical evaluation: based on revised Venous Clinical Severity Score rVCSS , Villalta score and CEAP classification . rVCSS includes 10 items, such as pain, varicose veins, oedema, skin pigmentation, inflammation, skin induration, number of active ulcers, ulcer size, duration of ulcer, and application of pressure therapy. Each item is scored from 0 to 3 according to the severity, and the total score is 30. A higher score indicates higher severity. And using villlata score It can be used to both diagnose and categories the severity of the condition. The Villalta score involves both the patient who grades the presence and severity (0-3 points) of five symptoms ( pain , cramps, heaviness, parasthesia and pruritus ) and and the physician who grades six clinical signs(Pre-tibial oedema, Hyper-pigmentation, Redness, Venous Ectasia, ain on calf compression, ulcers) (0-3 points) after examination of the lower limb. Also the clinical severity of the venous disease will be graded according to the clinical, etiological, anatomical, and pathophysiological (CEAP) scoring system, and assessment of venous ulcer assessment (by onset, course, duration, site, size, shape
Detailed description
Study Procedures and Interventions:
All participants will receive standardized venous ulcer care, including wound assessment, appropriate dressing according to the amount of exudate, and elastic compression using class II elastic stockings. Wound care will be provided twice weekly in the vascular surgery clinic by the study investigators. Debridement and wound culture with sensitivity testing will be performed when clinically indicated.
Participants assigned to the interventional treatment will undergo endovascular iliac venous recanalization and stenting. The ipsilateral great saphenous vein, popliteal vein, or femoral vein will be used as the preferred venous access according to the anatomical characteristics of each case. Procedures will be performed under ultrasound guidance.
After venous access, an antegrade venogram will be obtained to assess the venous anatomy and determine the location and extent of iliac venous obstruction. A guidewire will be advanced across the obstructed segment, followed by balloon venoplasty using an appropriately sized balloon. A dedicated self-expanding venous stent will then be deployed across the obstructed segment. Stent diameter will be selected according to the venous anatomy and vessel dimensions, with adequate post-dilatation when required. Completion venography will be performed to assess the final venous flow and stent position.
Following the procedure, venous access sites will be compressed with a sterile dressing. Antithrombotic treatment will be administered according to the study protocol. Low-molecular-weight heparin will be administered at a dose of 5000 IU every 12 hours after stent implantation, followed by therapeutic anticoagulation with warfarin targeting an international normalized ratio of 2-3 or rivaroxaban 20 mg once daily for at least 1 year after hospital discharge.
Postoperative Follow-up:
Clinical follow-up will be performed at 7 days, 1 month, 3 months, 6 months, and 12 months after treatment. Follow-up assessments will include venous ulcer healing, ulcer diameter and depth, time to complete healing, and changes in venous clinical severity and quality-of-life scores. Venous duplex ultrasound will be performed during follow-up to assess stent patency. Computed tomography venography will be performed in cases of suspected stent occlusion, recurrent symptoms, or recurrent venous ulceration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- choronic non healing venous ulcer patients with post thrombotic syndrome with iliofemoral venous occlusion
| Arm | Type | Receives |
|---|---|---|
| Iliofemoral dedicated venous stenting | Experimental | Procedure: dedicated venous stenting, Device: Dedicated venous stent / iliofemoral dedicated venous stentingParticipants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic non-healing venous ulcer associated with iliofemoral post-thrombotic syndrome.
- CEAP clinical classification C6.
- Iliofemoral post-thrombotic venous obstruction confirmed by appropriate venous imaging.
- Age 18 years or older.
- Ability to provide informed consent.
Key exclusion criteria (10 listed)
- Nonthrombotic iliac vein lesion (NIVL).
- Post-phlebitic femoropopliteal venous lesions with a patent iliac vein.
- CEAP clinical classification other than C6.
- Previous venous intervention.
- Active pathological ulcer unrelated to post-thrombotic venous disease.
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 |
|---|---|---|
| dedicated venous stentingAlso: venoplastyiliofemoral dedicated venous stenting | Procedure or surgery | Iliofemoral dedicated venous stenting |
| Dedicated venous stent / iliofemoral dedicated venous stentingParticipants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy. | Device | Iliofemoral dedicated venous stenting |
Primary outcome
complete healing of venous ulcer
Time frame: 12 months
Proportion of participants with complete healing of the venous ulcer at 12 months after iliofemoral venous stenting.
3 secondary outcomes
Time to complete venous ulcer healing
Time frame: 12 months
Change in rVCSS
Time frame: 12 months
Venous ulcer recurrence
Time frame: 12 months
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 13 Aug 2026.
- Results publication: PubMed 32113854Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27.
- Results publication: PubMed 26992578Marston WA, Vasquez MA, Lurie F, Wakefield TW, Rabe E, Shortell CK, Lohr JM, Passman MA, McLafferty RB; American Venous Forum Outcomes Working Group. Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS). J Vasc Surg Venous Lymphat Disord. 2013 Jul;1(3):219-24. doi: 10.1016/j.jvsv.2012.10.059. Epub 2013 May 18.
- Results publication: PubMed 37651058Wang J, Smeath E, Lim HY, Nandurkar H, Kok HK, Ho P. Current challenges in the prevention and management of post-thrombotic syndrome-towards improved prevention. Int J Hematol. 2023 Nov;118(5):547-567. doi: 10.1007/s12185-023-03651-6. Epub 2023 Aug 31.
- Results publication: PubMed 41921606Pappas CP, Lakhanpal G, Kennedy R, Lakhanpal S, Shahi S, Pappas PJ. Outcomes of iliofemoral venous stenting in women with venous ulcers. J Vasc Surg Venous Lymphat Disord. 2026 Jul;14(4):102492. doi: 10.1016/j.jvsv.2026.102492. Epub 2026 Mar 30.
- Results publication: PubMed 39393577Jalaie H, Barbati ME, Piao L, Doganci S, Kucher N, Dumantepe M, Hartung O, Lichtenberg M, Black S, O'Sullivan G, Avgerinos ED, Davies AH, Razavi MK; International CVO Classification Study Group. Prognostic Value of a Classification System for Iliofemoral Stenting in Patients with Chronic Venous Obstruction. Eur J Vasc Endovasc Surg. 2025 Feb;69(2):315-322. doi: 10.1016/j.ejvs.2024.10.002. Epub 2024 Oct 10.
- Individual participant dataSharing planned: Yes. Share for MD
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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.
Naglaa Fathy Naglaa Fathy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dedicated venous stenting and Dedicated venous stent / iliofemoral dedicated venous stenting in people with Vascular and DVT - Deep Vein Thrombosis, 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Aug 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 Nancy salah Nancy Salah (Egypt : 01122646814, postgrad@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete healing of venous ulcer (time frame: 12 months). 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 NCT07762222, which also lists 5 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 13 Aug 2026.