Wounds
Conditions
Keywords
Angiogenesis, Post surgical dehisced wounds of the lower extremity
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® therapy results in increased angiogenesis compared to moist wound therapy.
Interventions
DEVICEVAC® Therapy System
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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. | — |
Outcome results
None listed