Evaluate the Impact of Drawtex in Venous Leg Ulcers



Status:Completed
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:October 2010
End Date:August 2011

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Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers

This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing
against wound bioburden in moderately to highly exuding venous leg ulcers.

Each subject is expected to participate in this study for a period of four weeks or until
reepithelialization, whichever occurs first. Subjects may participate for an additional
period of four weeks or until reepithelialization, whichever occurs first: this it to be
decided by the investigator and will be determined by the accessibility of the patient
(physical location) and the suitability of the wound to further treatment. The maximum time
period for the study is 8 weeks. The minimum time frame is at least 4 week, or until
reepithelialization occurs.

Inclusion Criteria:

- Subject > 18 years.

- Subject is attending weekly office visits at SW Wound Care Center as an out-patient.

- Subject has a moderately to highly exudative venous leg ulcer that would be indicated
for treatment with Drawtex

- Subject or is informed about the trial, understands its nature of the study and
provides written informed consent prior to study enrollment.

- Subject is willing and able to comply with all specified care and visit requirements

Exclusion Criteria:

- Subject has a lesion that does not meet the inclusion criteria.

- Subject refuses to participate in the study.

- Subject already participates in the this study with one wound (only one wound per
subject is allowed)

- Subject has known sensitivity to the trial product or any of its compounds.

- Subject is expected to be non-compliant.

- Subject's lesion is a primary skin cancer.

- Subject's lesion is the manifestation of a metastasis.

- Subject is pregnant.
We found this trial at
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Lubbock, TX
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