ISRCTN28965380已完成未知
Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Harvest Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers
Harvest Technologies Corp. (USA)0 个研究点目标入组 59 人开始时间: 2005年10月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age >18 years
- •2. Patient and/or his/her legal representative has read and signed the IRB approved Informed Consent Form before treatment
- •3. Patient or caregiver are willing and able to participate in the clinical trial for the duration of the study and are able to visit the clinic weekly
- •4. Patient is willing to have blood drawn weekly
- •5. Patient is compliant with standard wound care regimen assessed over 3 initial observational visits each 7 days apart
- •6. Patient is diabetic (on insulin or oral hypoglycemic agent) HbAlC <10
- •a. Ulcer present =4 weeks
- •b. Ulcer is located on lower extremity (below knee)
- •c. Ulcer extends through the dermis and into subcutaneous tissue and may involve tendon, muscle and/or bone
- •d. Ulcer size: 0.7 cm^2 to 25 cm^2
- •8. Circulation status:
- •a. Minimal disease with palpable pulses or ABI >0.7
- •b. Previously revascularized at least 4 weeks prior to enrolment by bypass or endovascular therapy
- •c. Compromised circulation with ABI 0.4-0.7 in patient not deemed to be a candidate for revascularization because of prohibitive anatomic or physiologic consideration
- •9. Hematological:
- •a. Hct =30%
- •b. Platelet count =100,000
- •10. Adequate venous access for phlebotomy
- •11. Reliable access to outpatient dressing care i.e. home nursing service, family member, patient
- •12. Serum Albumin >2.5 mg/dl
- •(Stratification: Wagner classification stage I or II OR stage III, creatinine clearance <40 OR =40, Ankle Brachial Index [ABI] 0.4-0.7 OR >0.7)
排除标准
- •1. Ulcer is located in area of radiation treatment
- •2. Active malignancy
- •3. Being treated with immunosuppressant drugs
- •4. Patient received biological treatment(s) within 30 days
- •5. Active infection - if osteomyelitis has been diagnosed, patient may be enrolled only after infection has been controlled
- •6. Patient has a known alcohol or drug abuse
- •7. Patient has a non-study ulcer on the study lower extremity that is located within 2.0 cm from the study ulcer at Day 0
- •8. Patient has been previously diagnosed with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) or hepatitis
- •9. Patient is undergoing dialysis
- •10. Ankle Brachial Index <0.4
- •11. Ankle Brachial Index 0.4-0.7 in patient appropiate for revascularization
- •12. Venous stasis ulcers. Low leg ulcers in the presence of any of the following are to be excluded:
- •a. Presence of lipodermatosclerosis in the gaitor area of the calf
- •b. Presence of varicose veins
- •c. History of deep venous thrombosis in the index limb
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