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Clinical Trials/NCT01594658
NCT01594658
Completed
Not Applicable

Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment

Hospital Occidente de Kennedy1 site in 1 country46 target enrollmentJuly 2011
ConditionsVenous Ulcer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Ulcer
Sponsor
Hospital Occidente de Kennedy
Enrollment
46
Locations
1
Primary Endpoint
Venous Ulcer Treatment with Foam Versus Conservative Treatment
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The venous ulcer due to venous insufficiency causes an important morbility to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 6 months to several years. therapeutical alternatives, which can guarantee optimal, fast and persistent in time healings, should be identified.

The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration after six months from the intervention, compared with conservative medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of superficial venous reflux will diminish the time of ulcer healing compared with standard handling.

Detailed Description

to determine healing rates following ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) in patients with open (clinical,etiologic, anatomic and pathophysiologic (CEAP) classification, C6) chronic venous ulceration ( CVU) in a randomised clinical trial of foam sclerotherapy for patients with venous ulcer

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
September 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Occidente de Kennedy
Responsible Party
Principal Investigator
Principal Investigator

ernesto nieves

medical doctor

Hospital Occidente de Kennedy

Eligibility Criteria

Inclusion Criteria

  • Presence of Venous Ulcer confirmed by CEAP C6
  • Chronic venous ulcer present for at least 4 weeks
  • Ankle-arm index greater or equal to 0.8 mmHg

Exclusion Criteria

  • Severe hepatic, cardiac or pulmonary disease
  • Deep venous thrombosis
  • Active participation in other clinical trials

Outcomes

Primary Outcomes

Venous Ulcer Treatment with Foam Versus Conservative Treatment

Time Frame: 6 months

Number of participants with healing of venous ulcer after six months from the intervention.

Study Sites (1)

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