NCT00234559撤回不适用
A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- KCI USA, Inc
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
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
次要结局
- 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.
研究者
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