NCT00224796已完成4 期
A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure® Therapy in the Treatment and Blinded Evaluation of Amputation Wounds of the Diabetic Foot
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 146
- 主要终点
- To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.
研究概览
简要总结
The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Secondary objectives include evaluating the acceleration of wound closure, facilitation of surgical closure, incidence of foot salvage, and incidence of wound complications.
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
- •Presence of a diabetic foot amputation wound up to the transmetatarsal region of the foot
- •Evidence of adequate perfusion by one of the following on the affected extremity, (within the past 60 days):
- •Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or
- •Ankle brachial index (ABIs) with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or
- •Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
- •Age ≥ 18 years of age
- •HbA1c ≤ 12% (collected within the last 90 days.)
- •Evidence of adequate nutrition by one of the following:
- •Lab results reflecting Pre-Albumin ≥16 mg/dl and Albumin level is ≥3 g/dl (during the seven days prior to the study period), or
- •A nutritional consult will be done and with appropriate supplementation started. Proper documentation on (case report forms)CRFs is needed.
排除标准
- •Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
- •Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency
- •Untreated infection or cellulitis at site of target wound
- •Presence of untreated osteomyelitis
- •Collagen vascular disease
- •Malignancy in the wound
- •Presence of necrotic tissue in the wound
- •Uncontrolled hyperglycemia
- •Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
- •Prior V.A.C.® therapy within 30 days.
- •Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (HBO) therapy within 30 days.
- •Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
- •Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraf, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
结局指标
主要结局
To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.
次要结局
- To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study
- To determine the incidence of complications
- To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure
- To determine the change in wound area over time
- To determine the effect of V.A.C. ® Therapy on the quality of life
研究者
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