Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Venous Ulcer Recurrent
• Intervention / Treatment: Device: compression therapy; Procedure: iliac vein stenting

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients fulfilling both the inclusion and the exclusion criteria will be included in the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ulcer healing within 6 months	comparing the results of both modalities in recurrent venous ulcer healing	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 26, 2020
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Disease Attributes; Leg Ulcer; Skin Ulcer; Varicose Veins; Recurrence; Varicose Ulcer
• Other Study ID Numbers: stenting & compression therapy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No