WoundsNCT00234559
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
A study testing VAC® Therapy System in people with Wounds, run by KCI USA, Inc.
Trial summary
The purpose of this study is to determine: 1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy. 2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- VAC® Therapy System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Aug 2007
- 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
- Patient is male or female and > 18 years old.
- Patient or patient's legal authorized representative is willing to sign informed consent.
- Patient has a post surgical dehisced wound of the lower extremity for longer than two weeks and less than one month.
- Patient has transcutaneous oximetry (TcPO2) evaluation that demonstrated tissue hypoxia in the periwound region, as indicated by a reading of 10-40 mmHg within the prior two weeks.
- Ankle Brachial Index > 0.7 within the prior two weeks.
- Patient is not pregnant (pregnancy test is negative) and non-lactating at Visit 1.
- Patient does not plan on becoming pregnant during the course of the study.
- Patient is willing to use effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least one year prior to enrollment in study.
Who cannot join
- Diagnosed and untreated wound infection.
- Poor nutrition status as evidenced by pre-albumin < 12mg/dl within the past 30 days or extracellular mass < 95%.
- Presence of sickle cell disease.
- Presence of connective tissue disease (e.g. history of or active lupus).
- Hemoglobin A1c (HbA1c) levels greater than 9% thirty days prior to screening visit (if patient is confirmed diabetic).
- Treatment with an investigational therapy within the previous 30 days.
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- Lower extremity wound (under consideration for study) with malignancy.
- Lower extremity wound (under consideration for study) with untreatable cellulitis.
- Presence of untreated osteomyelitis.
- Presence of any systemic hematologic disorder or condition that would impede healing.
- History of radiation to the wound area.
- History of drugs that may delay wound healing.
- History of thermal injury to the wound area.
- Prior VAC® therapy to the wound within 30 days of enrollment.
- Current or prior treatment with hyperbaric oxygen therapy (HBO) or warm-up therapy to the same wound.
- Recent diagnosis of cancer or active management of cancer within the last year.
- Treatment with skin or dermal substitutes or dressings with living cells capable of producing growth factors within the previous 30 days.
- End stage renal disease.
- History of alcohol or drug abuse that may impact protocol compliance or delay wound healing.
- Known hypersensitivity to hydrogel or any disposable component of the VAC® Therapy System.
- Necrotic tissue with eschar present which cannot be debrided.
- Any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
About this study
Official title: A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis
The purpose of this study is to determine:
- If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.
- If VAC® therapy results in increased angiogenesis compared to moist wound therapy.
- Conditions
- Wounds
- Being tested
- VAC® Therapy System
- Keywords
- Angiogenesis, Post surgical dehisced wounds of the lower extremity
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC® Therapy SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28
Secondary outcomes (1)
Increased angiogenesis of the lower extremity wound will be quantified using the MicroScan™ (video microscope) at Day 0, Day 3, Day 7, Day 21, Day 28, Day 42, and at follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: Study terminated due to no subject enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey A Niezgoda, M.D., Principal investigator, St. Luke's Medical Center of Aurora Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234559
- Sponsor's protocol ID
- VACP2005-001
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2005
- Last updated
- 2 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis
- ClinicalTrials.gov ID
- NCT00234559
- Acronym / sponsor ID
- VACP2005-001
- Conditions
- Wounds
- Keywords
- Angiogenesis, Post surgical dehisced wounds of the lower extremity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to no subject enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Oct 2005 (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.
The purpose of this study is to determine:
- If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.
- If VAC® therapy results in increased angiogenesis compared to moist wound therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is male or female and > 18 years old.
- Patient or patient's legal authorized representative is willing to sign informed consent.
- Patient has a post surgical dehisced wound of the lower extremity for longer than two weeks and less than one month.
- Patient has transcutaneous oximetry (TcPO2) evaluation that demonstrated tissue hypoxia in the periwound region, as indicated by a reading of 10-40 mmHg within the prior two weeks.
- Ankle Brachial Index > 0.7 within the prior two weeks.
Key exclusion criteria (22 listed)
- Diagnosed and untreated wound infection.
- Poor nutrition status as evidenced by pre-albumin < 12mg/dl within the past 30 days or extracellular mass < 95%.
- Presence of sickle cell disease.
- Presence of connective tissue disease (e.g. history of or active lupus).
- Hemoglobin A1c (HbA1c) levels greater than 9% thirty days prior to screening visit (if patient is confirmed diabetic).
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 |
|---|---|---|
| VAC® Therapy System | Device | – |
Primary outcome
Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28
1 secondary outcome
Increased angiogenesis of the lower extremity wound will be quantified using the MicroScan™ (video microscope) at Day 0, Day 3, Day 7, Day 21, Day 28, Day 42, and at follow up visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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.
Jeffrey A Niezgoda, M.D. principal investigator
St. Luke's Medical Center of Aurora Health Care
Questions about this trial
What is this clinical trial studying?
A study testing VAC® Therapy System in people with Wounds, run by KCI USA, Inc.
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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28. 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 2 Dec 2024.