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Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

A

Assiut University

Status

Unknown

Conditions

Venous Ulcer Recurrent

Treatments

Device: compression therapy
Procedure: iliac vein stenting

Study type

Observational

Funder types

Other

Identifiers

NCT04834232
stenting & compression therapy

Details and patient eligibility

About

Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

12 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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