Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

NCT04834232 | Unknown

• 1 other identifier: stenting & compression therapy
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Ulcer Recurrent

Outcome Measures

Primary Outcomes (1)

• ulcer healing within 6 months

  comparing the results of both modalities in recurrent venous ulcer healing

  baseline

Secondary Outcomes (4)

• patency on stents

  baseline

• compliance

  baseline

• assessment of venous disability score (VDS)

  baseline

• assessment of venous clinical severity score

  baseline

Interventions

compression therapy DEVICE

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.

iliac vein stenting PROCEDURE

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

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

Location

Related Publications (4)

• 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.

  PMID: 23433816 BACKGROUND

• 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.

  PMID: 29942813 BACKGROUND

• 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.

  PMID: 24953000 BACKGROUND

• 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.

  PMID: 25165679 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

EG (1)