Moderatley to Highly Exuding Venous Leg UlcersNCT01319123
Evaluate the Impact of Drawtex in Venous Leg Ulcers
A study testing Drawtex dressing in people with Moderatley to Highly Exuding Venous Leg Ulcers, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderatley to Highly Exuding Venous Leg Ulcers
- What is being tested?
- Drawtex dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
Official title: 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.
Read the detailed 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.
- Being tested
- Drawtex dressing
- Keywords
- dressing for venous leg ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawtex dressingDevice
Also called Beier Drawtex
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers
| Study group | Role | What they receive |
|---|---|---|
| wound dressing | Other | The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers. Receives: Device: Drawtex dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the impact of Drawtex on wound surface bioburden.
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.• The safety of Drawtex will be measured by the number and type of any adverse events. Patient's tolerance and acceptance of the different dressings
Measured: 2 years
Secondary outcomes (1)
Tolerance
To further investigate whether Drawtex
- Will have an overall benefit on the wound healing process.
- Patient's tolerance and acceptance of the dressings. The overall effect on wound healing, as expressed by percentages of necrosis, slough, granulation and/or epithelium at the wound surface.
- Condition of periwound skin
- Mobility restrictions, related to the dressing
- The number of dressings per dressing change, the number of dressing changes and the amount of nursing time involved
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderatley to Highly Exuding Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beier Drawtex Healthcare, (PTY). Ltd
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
- Investigators
- Randall D Wolcott, M.D., Principal investigator, Southwest Regional Wound Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319123
- Sponsor's protocol ID
- 56-RW-019
- Status last verified
- Oct 2012
- First submitted
- 10 Mar 2011
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01319123
- Acronym / sponsor ID
- 56-RW-019
- Keywords
- dressing for venous leg ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Collaborators
- Beier Drawtex Healthcare, (PTY). Ltd
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wound dressing | Other | Device: Drawtex dressingThe dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drawtex dressingAlso: Beier DrawtexThe dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers | Device | wound dressing |
Primary outcome
To investigate the impact of Drawtex on wound surface bioburden.
Time frame: 2 years
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.• The safety of Drawtex will be measured by the number and type of any adverse events. Patient's tolerance and acceptance of the different dressings
1 secondary outcome
Tolerance
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall D Wolcott, M.D. principal investigator
Southwest Regional Wound Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drawtex dressing in people with Moderatley to Highly Exuding Venous Leg Ulcers, run by Southwest Regional Wound Care Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the impact of Drawtex on wound surface bioburden. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.