NCT01921491已完成不适用
DHACM vs Other Commercially Available Treatments
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control.
研究概览
简要总结
The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs).
详细描述
This is a prospective, stratified, randomized, controlled, comparative, parallel group, multi-center clinical trial comparing the proportion of ulcers completely healed by use of dehydrated human amnion/chorion membrane (dHACM) placed weekly versus placement of bioengineered skin substitute (BSS) placed weekly, versus standard of care in diabetic patients with a diabetic foot ulcer who have adequate arterial perfusion as defined in section, 2.0 (Patient Eligibility), for wound healing to the affected limb.
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
- •Patients age 18 or older.
- •Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- •Patient's ulcer must be diabetic in origin and larger than 1 cm
- •Note: Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
- •Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- •Ulcer must be present for a minimum of four weeks before enrollment/ randomization, with documented failure of conventional ulcer therapy to heal the wound. A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
- •Additional wounds may be present but not within 3 cm of the study wound.
- •Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
- •Patient's ulcer must exhibit no clinical signs of infection.
- •Serum Creatinine less than 3.0mg/dl within last six months.
- •HbA1c less than or equal to 12% within last 90 days.
- •Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- •Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
- •ABIs with results of ≥0.7 and ≤1.2, OR
- •Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg.
排除标准
- •Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- •Patients whose index diabetic foot ulcers are greater than 25 cm
- •Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
- •Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six months.
- •Patients with a known history of poor compliance with medical treatments.
- •Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
- •Patients who are currently receiving radiation therapy or chemotherapy.
- •Patients with known or suspected local skin malignancy to the index diabetic ulcer.
- •Patients diagnosed with autoimmune connective tissues diseases.
- •Non-revascularizable surgical sites.
- •Active infection at site.
- •Any pathology that would limit the blood supply and compromise healing.
- •Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
- •Patients who are pregnant or breast feeding.
- •Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
- •Known allergy to Gentamicin or Streptomycin, or to bovine collagen.
- •Patients with known hypersensitivity to components of any treatment used in the trial.
- •Wounds greater than one year in duration without intermittent healing.
- •Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
- •Patients taking Cox-2 inhibitors.
- •Planned use of Dakin's solution, Mafenide Acetate, Scarlet Red Dressing, Tincoban, Zinc Sulfate, Povidone Iodine solution, Mafenide Acetate, Polymyxin/Nystatin or Chlorhexidine during trial.
结局指标
主要结局
Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control.
时间窗: 6 weeks
Visitrak Wound Measurement System
次要结局
- Proportion of patients achieving 100% epithelialization in dHACM group vs other commercially available product and control.(12 weeks)
- Cost effectiveness of each treatment modality.(12 weeks)
研究者
研究点 (4)
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