Evaluate the Impact of Drawtex in Venous Leg Ulcers

Southwest Regional Wound Care Center

Status

Completed

Conditions

Moderatley to Highly Exuding Venous Leg Ulcers

Treatments

Device: Drawtex dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT01319123

56-RW-019

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.