Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

• Conditions: Venous Ulcer Recurrent

• Registration Number: NCT04834232
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2020-09-26
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-03
• Last Update Submitted: 2021-04-03
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Study Start: 2021-05-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ulcer healing within 6 months	baseline	comparing the results of both modalities in recurrent venous ulcer healing

Secondary Outcome Measures

Name	Time	Method
compliance	baseline	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
patency on stents	baseline	primary assisted patency included those requiring reintervention to maintain patency; and secondary patency was defined as stents that were blocked and successfully reopened.
assessment of venous clinical severity score	baseline	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.
assessment of venous disability score (VDS)	baseline	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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Asyut, Egypt