NCT00432965已完成不适用
KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 335
- 试验地点
- 25
- 主要终点
- Incidence of Complete Ulcer Closure Closure.
研究概览
简要总结
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.
The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.
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 calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.)
- •DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E)
- •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 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 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
- •Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency
- •Untreated infection or cellulites at site of target ulcer
- •Presence of untreated osteomyelitis
- •Collagen vascular disease
- •Malignancy in the ulcer
- •Presence of necrotic tissue
- •Uncontrolled hyperglycemia
- •Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
- •Open amputations
- •Prior V.A.C. therapy within 30 days.
- •Current or prior normothermic (Warm-UP®) or 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: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
- •Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study
- •Pregnant or nursing mothers.
研究组 & 干预措施
VAC Therapy
Experimental
Treatment of Diabetic Foot Ulcers with VAC Therapy
干预措施: VAC Therapy (Device)
Moist Wound Therapy
Active Comparator
Moist Wound Therapy (standard of care)
干预措施: Moist Wound Therapy (Device)
结局指标
主要结局
Incidence of Complete Ulcer Closure Closure.
时间窗: Days 0-114
次要结局
未报告次要终点
研究者
研究点 (25)
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