A Comparison of Total Contact Casting (TCC-EZ) Using Human Amnion Allograft (AmnioExcel) Versus Total Contact Casting (TCC-EZ) and Standard Wound Care in Treating Diabetic Foot Ulcers (TAD)
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Time to closure of a Diabetic Foot Ulcer using Human Amnion Allograft and Total Contact Casting vs Standard Wound Care and Total Contact Casting.
研究概览
简要总结
A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment.
Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.
详细描述
A TCC offloads pressure and is the gold standard for DFU treatment, as documented in several studies. The TCC results in an average healing rate of 80-90% within 6 weeks, yet only about 6% of DFU patients receive the TCC. The TCC requires special provider training for application. Given the high efficacy and low complication risk for the TCC, clinicians need to use the TCC to treat DFUs. Literature supports use of the TCC combined with other wound bed treatment modalities. AmnioExCel® is a dehydrated, extracellular human amnion derived tissue allograft that provides a structural tissue matrix that promotes angiogenesis, collagen matrix formation and re-epithelization (Werber et al., 2013). This study will look at whether or not combining AmnioExCel® and a TCC-EZ results in a better healing rate than TCC-EZ and standard wound care.
Purpose/Research Questions:
The purpose of this prospective clinical trial is to compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Casting (TCC-EZ) with AmnioExCel® and TCC-EZ with standard treatment.
Research Questions:
- What is the difference in reduction in wound bed area for diabetic foot ulcers (DFUs) treated with Total Contact Casting TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the difference in time to closure for DFUs treated with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the difference in cost of treatment for a diabetic foot ulcer treated with TCC-EZ and AmnioExCel® as compared to TCC-EZ with standard wound treatment?
- What is the relationship between the hemoglobin A1c test(HbA1c) or glycated hemoglobin test and reduction in wound bed area for DFUs treated with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the relationship between HbA1c and time to closure for DFUs with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the subjects' reported satisfaction using TCC-EZ?
- What is the reoccurrence of DFUs in a 90 day post treatment follow up?
- What are the characteristics of adverse side effects using TCC-EZ and AmnioExCel®?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be included if they are 18 years of age or older
- •have a diagnosis of diabetes type 1 or 2
- •random blood sugar of 450 or < and HbA1c of 15% or < drawn quarterly prior to study
- •the ulcer has been present for a minimum of 2 weeks under the current investigators care
- •the foot ulcer is on the plantar surface of the forefoot or heel and > 0.5cm2 in size at day 0
- •patient's ulcer extends through the dermis into subcutaneous tissue but without exposure of bone or joint capsule classified as a grade 2 or 3 DFU using the University of Texas diabetic wound classification system
- •ulcer is free of necrotic debris and appears to be made up of healthy vascularized tissue
- •and subject's foot has evidence of adequate perfusion with an ankle-brachial index of > 0.7 and < 1.2.-
排除标准
- •Subjects younger that 18 years of age
- •no current diagnosis of diabetes type 1 or 2
- •has uncontrolled hyperglycemia random blood sugar of > 450 mg/dl
- •HbA1c > 15%
- •gangrene present on any part of the affected foot
- •ulcer's total surface area is > 20cm2
- •ulcer has decreased or increased in size by 50% or more during the screening period
- •presence of non-study ulcer located within 7.0 cm of the study ulcer at the beginning of the study day 0
- •and evidence of infection determined by the provider.
结局指标
主要结局
Time to closure of a Diabetic Foot Ulcer using Human Amnion Allograft and Total Contact Casting vs Standard Wound Care and Total Contact Casting.
时间窗: 12 weeks
Number of days to closure of the DFUs.
次要结局
未报告次要终点
研究者
Patricia Thompson
Clinical Associate Professor
University of North Dakota