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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wounds

Intervention / Treatment
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* Device: VAC® Therapy System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VAC® Therapy System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiogenesis, Post surgical dehisced wounds of the lower extremity