Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis

A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis

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.

Inclusion Criteria:

• 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 Criteria:

• 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.