Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer

NCT03666754

Venous Leg Ulcer

UNKNOWN NA

Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice

NCT03736941

Venous Leg Ulcer

UNKNOWN NA

Compliance of Compression Therapy in Healed Venous Ulcerations

NCT01680809

Venous Insufficiency

WITHDRAWN NA

Immediate Versus Early Endovenous Ablation In Venous Ulcer

NCT03795064

Venous Ulcer

COMPLETED NA

Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

NCT02395302

Venous Leg Ulcer Chronic Venous Insufficiency Venous Stasis Ulcer +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Ulcer Recurrent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

compression therapy

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.

Intervention Type DEVICE

iliac vein stenting

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes