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| Name | Class |
|---|---|
| Universidad El Bosque, BogotĆ” | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foam sclerotherapy | This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management |
| |
| Conservative | This arm only has medical standard handling (healings performed by the nurse group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foam sclerotherapy | Procedure | Foam application of 1% (SklerolĀ®, ICV Pharma, Bogota-Colombia), Reg INVIMA: 2002M-0001016, guided by ecography of insufficient superficial veins, doses from 10-40 cc of foam until obtaining endoluminal occlusion of the vein. The patient will rest for 8 minutes and then the leg will be covered with elastic bandage. |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Ulcer Treatment with Foam Versus Conservative Treatment | Number of participants with healing of venous ulcer after six months from the intervention. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with C6 by CEAP Clasification
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| Name | Affiliation | Role |
|---|---|---|
| Miguel A Ramirez, MD | Hospital Occidente de Kennedy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Occidente de Kennedy | Bogota | Cundinamarca | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20875753 | Background | Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5. doi: 10.1016/j.ejvs.2010.08.011. Epub 2010 Sep 27. | |
| 19616975 | Background |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| conservative | Procedure | This arm only has medical standard handling (healings performed by the nurse group) |
|
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| Darvall KA, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Ultrasound-guided foam sclerotherapy for the treatment of chronic venous ulceration: a preliminary study. Eur J Vasc Endovasc Surg. 2009 Dec;38(6):764-9. doi: 10.1016/j.ejvs.2009.05.027. Epub 2009 Jul 18. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |