Clinical trial NCT04834232: Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration
Official title: Comparative Study Between Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Ulcer Recurrent
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients fulfilling both the inclusion and the exclusion criteria will be included in the study.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* diabetic neuropathic ulcer.
* atypical site of venous ulcer.
* acute onset DVT.
* age \< 12 years.

Primary outcomes:
measure: ulcer healing within 6 months
timeFrame: baseline
Secondary outcomes:
measure: patency on stents
timeFrame: baseline
measure: compliance
timeFrame: baseline
measure: assessment of venous disability score (VDS)
timeFrame: baseline
measure: assessment of venous clinical severity score
timeFrame: baseline
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: 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.
citation: Xie 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.
citation: George 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.
citation: Nair 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.