A Prospective, Randomized, Multi-Center Comparative Study of Amniotic Membrane Wound Graft Application Versus Tissue Engineered Skin Substitute in the Management of Non Healing Diabetic Foot Ulcers
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetic Foot Ulcer
- 发起方
- Professional Education and Research Institute
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The number of participants out of 60 with complete healing of their diabetic foot ulcers as measured by complete epithialization of the foot wound comparing the two active treatment groups
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).
详细描述
Diabetes affects at least 9% of the population, or approximately 29 million people in the United States. Lower extremity ulcers are a serious complication for people with diabetes. Diabetic foot-related problems are the most frequent cause of hospitalization within this group and it is estimated that the total cost for treatment ranges from $10,000 to nearly $60,000 depending on ulcer severity and clinical outcomes. While many diabetic foot ulcers are superficial and can heal with conservative treatment, many are more severe and recalcitrant to standard of care (SOC). About a quarter of individuals with diabetes will develop a chronic non-healing ulcer over their lifetime and nearly 60 of every 10,000 individuals with diabetes will undergo a lower extremity amputation. Holzer and associates conducted a retrospective analysis of the costs for lower extremity ulcers in patients with diabetes and concluded that, given the high costs associated with treating these ulcers, the development of better treatment strategies is warranted. One such development in the treatment of chronic wounds is the use of amniotic membrane grafts. These materials have been used successfully for many years in the treatment of orthopedic, plastic/reconstructive, and urological applications. Initial studies have demonstrated the great success of amnionic membrane graft in the healing of chronic diabetic foot ulcers and it is believed that these grafts may be superior to older, more common skin substitutes.
研究者
入排标准
入选标准
- •Male or female age 18 or older
- •Informed consent must be obtained
- •Patient's ulcer must be diabetic in origin and larger than 1cm
- •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 duration, with documented failure of prior treatment to heal the wound.
- •Patient's ulcer must exhibit no clinical signs of infection.
- •Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle
- •Additional wounds may be present but not within 3cm of the study wound
- •Patient is of legal consenting age.
排除标准
- •Patients presenting with an ulcer probing to 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 25cm
- •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 as noted by serum blood testing within the last six months.
- •Patients with a known history of poor compliance with medical treatments.
- •6 Patients who 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 on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
- •Patients with uncontrolled autoimmune connective tissues diseases.
结局指标
主要结局
The number of participants out of 60 with complete healing of their diabetic foot ulcers as measured by complete epithialization of the foot wound comparing the two active treatment groups
时间窗: 6 weeks
Examine the number of patient that go onto complete healing
次要结局
- Cost effectiveness of each treatment modality.(12 weeks)
- Number of wounds healed(12 weeks)
- Time to healing/complete closure(12 weeks)