Venous Ulcer RecurrentNCT04834232
Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration
An observational study of Venous Ulcer Recurrent, run by Assiut University at 1 site in Egypt.
Trial summary
Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcer Recurrent
- What is being tested?
- compression therapy and iliac vein stenting
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Dec 2021
- 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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients fulfilling both the inclusion and the exclusion criteria will be included in the study.
Who may be able to join
- iliac vein compression.
- competent superficial venous system.
- isolated iliac vein lesion.
- patent femoropopliteal segment.
- ulcers located in the gaiter area.
- age > 12 years
- patients with ulcers located in the gaiter area, along with the following associated symptoms: leg heaviness, pain, varicose veins, edema, hemosedrin staining, pruritus, venous dermatitis, lipodermatoscelrosis, telangiectasias, corona phlebectatica, atrophie blanche and deformity of the leg.
Who cannot join
- patients with arterial disease in the same limb.
- patients with history of phlebitis.
- patients with congenital venous malformation
- patients with malignancy.
- patients with raised renal chemistry.
- patients with skin allergy.
Show all 10Show fewer
- diabetic neuropathic ulcer.
- atypical site of venous ulcer.
- acute onset DVT.
- age < 12 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration
Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration.
Read the detailed description
Venous ulceration is the most common etiology of lower extremity ulceration, approximately affecting almost 1% of the world's population. although its overall prevalence is relatively low, the refractory nature of venous ulceration increases morbidity, mortality , the patient's quality of life, and have a significant financial burden on the global budget. the primary risk factors are: old age, obesity deep venous thrombosis, phlebitis and previous leg injuries.
Iliac vein compression is a prevalent finding in patients with venous system pathology. It has a variety of causes, including May-Turner syndrome, endometriosis, bladder distension, common iliac artery aneurysm or internal iliac artery aneurysm.
venous compression becomes clinically significant when there's an increase in venous pressure, which in turn causes venous insufficiency. This contributes to the development of a state of chronic venous stasis, which sequentially causes pooling of blood, triggers further capillary damage and activates inflammatory mediators with the end result of venous ulcer development and impaired wound healing.
Located on bony prominences, venous ulcers are typically shallow, irregular with granulation tissue and fibrin present in their bases. A careful physical examination is required for a proper diagnosis, but he clinical challenge remains in its management, which includes prevention or the treatment of the clinical implications.
Treatment modalities should always be directed to the cause of the ulcer; they can be divided into:
- non invasive management, such as medical therapy, bandaging and dressings.
- invasive, such as endovascular and surgical techniques.
- Conditions
- Venous Ulcer Recurrent
- Being tested
- compression therapy, iliac vein stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression therapyDevice
compression bandaging or graduated compression hosiery consists of applying a type of elastic device, mainly on the limbs, to exert a controlled pressure on the lower limbs. The controlled pressure exerted by medical compression stockings reduces the diameter of major veins, thereby increasing the velocity and volume of blood flow, along with conditions beneficial for the healing of chronic inflammatory disorders (e.g. cellulitis, erysipelas, venous leg ulcers, etc.), through reduced pro-inflammatory cytokine levels and higher levels of the anti-inflammatory cytokines.
iliac vein stentingProcedure or surgery
using x-ray guidance (fluoroscopy) to place a an expandable metal mesh tube against the vein walls, acting as a scaffold to keep the veins open and improve blood flow
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer healing within 6 months
comparing the results of both modalities in recurrent venous ulcer healing
Measured: baseline
Secondary outcomes (4)
patency on stents
primary assisted patency included those requiring reintervention to maintain patency; and secondary patency was defined as stents that were blocked and successfully reopened.
Measured: baseline
compliance
to anticoagulation in case of stenting, or to elastic stocking in case of compression therapy, using methods that include patient self-reporting and clinical estimates
Measured: baseline
assessment of venous disability score (VDS)
the VDS evaluates the effect of venous disease by quantifying the level of work based disability.
It is scored on a scale of 0 to 3 (with 0 being the least severe and 3 the most severe), based on the ability to work an 8-hour day with or without provisions for external support.
Measured: baseline
assessment of venous clinical severity score
the score is obtained by imaging vein segments with duplex Doppler or phlebography.
It includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (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 Venous Ulcer RecurrentStudies 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, Mohamed hesham abdelrahem husiein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834232
- Sponsor's protocol ID
- stenting & compression therapy
- Status last verified
- Apr 2021
- First submitted
- 26 Sep 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20.
PubMed 23433816Xie T, Ye J, Rerkasem K, Mani R. The venous ulcer continues to be a clinical challenge: an update. Burns Trauma. 2018 Jun 15;6:18. doi: 10.1186/s41038-018-0119-y. eCollection 2018.
PubMed 29942813George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):330-6. doi: 10.1016/j.ejvs.2014.04.031. Epub 2014 Jun 18.
PubMed 24953000Nair B. Compression therapy for venous leg ulcers. Indian Dermatol Online J. 2014 Jul;5(3):378-82. doi: 10.4103/2229-5178.137822. No abstract available.
PubMed 25165679
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration
- ClinicalTrials.gov ID
- NCT04834232
- Acronym / sponsor ID
- stenting & compression therapy
- Conditions
- Venous Ulcer Recurrent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Apr 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.
Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration.
Detailed description
Venous ulceration is the most common etiology of lower extremity ulceration, approximately affecting almost 1% of the world's population. although its overall prevalence is relatively low, the refractory nature of venous ulceration increases morbidity, mortality , the patient's quality of life, and have a significant financial burden on the global budget. the primary risk factors are: old age, obesity deep venous thrombosis, phlebitis and previous leg injuries.
Iliac vein compression is a prevalent finding in patients with venous system pathology. It has a variety of causes, including May-Turner syndrome, endometriosis, bladder distension, common iliac artery aneurysm or internal iliac artery aneurysm.
venous compression becomes clinically significant when there's an increase in venous pressure, which in turn causes venous insufficiency. This contributes to the development of a state of chronic venous stasis, which sequentially causes pooling of blood, triggers further capillary damage and activates inflammatory mediators with the end result of venous ulcer development and impaired wound healing.
Located on bony prominences, venous ulcers are typically shallow, irregular with granulation tissue and fibrin present in their bases. A careful physical examination is required for a proper diagnosis, but he clinical challenge remains in its management, which includes prevention or the treatment of the clinical implications.
Treatment modalities should always be directed to the cause of the ulcer; they can be divided into:
- non invasive management, such as medical therapy, bandaging and dressings.
- invasive, such as endovascular and surgical techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients fulfilling both the inclusion and the exclusion criteria will be included in the study.
Key inclusion criteria (7 listed)
- iliac vein compression.
- competent superficial venous system.
- isolated iliac vein lesion.
- patent femoropopliteal segment.
- ulcers located in the gaiter area.
Key exclusion criteria (10 listed)
- patients with arterial disease in the same limb.
- patients with history of phlebitis.
- patients with congenital venous malformation
- patients with malignancy.
- patients with raised renal chemistry.
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 |
|---|---|---|
| compression therapycompression bandaging or graduated compression hosiery consists of applying a type of elastic device, mainly on the limbs, to exert a controlled pressure on the lower limbs. The controlled pressure exerted by medical compression stockings reduces the diameter of major veins, thereby increasing the velocity and volume of blood flow, along with conditions beneficial for the healing of chronic inflammatory disorders (e.g. cellulitis, erysipelas, venous leg ulcers, etc.), through reduced pro-inflammatory cytokine levels and higher levels of the anti-inflammatory cytokines. | Device | – |
| iliac vein stentingusing x-ray guidance (fluoroscopy) to place a an expandable metal mesh tube against the vein walls, acting as a scaffold to keep the veins open and improve blood flow | Procedure or surgery | – |
Primary outcome
ulcer healing within 6 months
Time frame: baseline
comparing the results of both modalities in recurrent venous ulcer healing
4 secondary outcomes
patency on stents
Time frame: baseline
compliance
Time frame: baseline
assessment of venous disability score (VDS)
Time frame: baseline
assessment of venous clinical severity score
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 23433816Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20.
- Background: PubMed 29942813Xie T, Ye J, Rerkasem K, Mani R. The venous ulcer continues to be a clinical challenge: an update. Burns Trauma. 2018 Jun 15;6:18. doi: 10.1186/s41038-018-0119-y. eCollection 2018.
- Background: PubMed 24953000George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):330-6. doi: 10.1016/j.ejvs.2014.04.031. Epub 2014 Jun 18.
- Background: PubMed 25165679Nair B. Compression therapy for venous leg ulcers. Indian Dermatol Online J. 2014 Jul;5(3):378-82. doi: 10.4103/2229-5178.137822. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Ulcer Recurrent, 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 7 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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?
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?
ulcer healing within 6 months (time frame: baseline). 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 NCT04834232, 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 8 Apr 2021.