Status:
WITHDRAWN
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
Lead Sponsor:
KCI USA, Inc
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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® thera...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00234559
Start Date
September 1 2005
End Date
August 1 2007
Last Update
December 2 2024
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