Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers

KCI USA, Inc0 个研究点开始时间: 2012年6月最近更新: 2024年11月25日

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: Percentage of wounds closed

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

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

•Wound < 10 cm in greatest diameter
•Wound age > 4 weeks and patient shows < 50% wound area healing after 4 weeks of treatment
•Patient > 18 years of age
•Patient is willing and able to sign consent
•Patient is willing and able to complete study visits and comply with study dressing protocols

排除标准

•Wound size reduction of > 50% in last 4 weeks of treatment
•Patients with active wound infections, including cellulitis and osteomyelitis
•Patients with wounds not able to have eschar debrided
•ABI < 0.65 or SPP < 30mmHg
•Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
•Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc.
•Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial.
•Pregnant patients
•Patients unable to tolerate NPWT
•Patients with dialysis dependent ESRD
•Index ulcer is on the plantar surface of the foot

结局指标

主要结局

Percentage of wounds closed

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方

KCI USA, Inc

申办方类型

Industry

责任方

Sponsor

相似试验

Unknown

1 期

Exploratory Clinical Study of Apatinib and SHR-1210 in Treating Advanced Hepatocellular Carcinoma or Gastric CancerGastric CancerHepatocellular Carcinoma

NCT02942329The Affiliated Hospital of the Chinese Academy of Military Medical Sciences60

已完成

4 期

Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)Rhinitis, Allergic, Perennial

NCT00806754AstraZeneca340

尚未招募

1 期

Combination Immunotherapy Targeting SarcomasOsteoid SarcomaSarcomaEwing Sarcoma

NCT04433221Shenzhen Geno-Immune Medical Institute20

已完成

3 期

A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical TherapyPlaque Psoriasis

NCT03930186Amgen152

已完成

1 期

Radiotherapy & Combi in Metastatic MelanomaMetastatic Melanoma

NCT02392871Melanoma and Skin Cancer Trials Limited10