Effectiveness of Supra SDRM® vs. Fibracol Plus Collagen in the Treatment of Diabetic Foot Ulcers: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time to heal
研究概览
简要总结
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.
详细描述
Chronic wounds are those that fail to proceed through the normal phases of wound healing. They pose a high risk for infection and risk complications resulting in amputation. A plethora of wound treatment modalities are commercially available to help improve patient outcomes. However, even when combined with a good standard of care practices and wound dressings, they may not be sufficient to promote timely wound closure. Cellular and/or tissue- based products (CTPs) may provide a healing advantage over traditional dressings. CTPs are derived from human (allograft), animal (xenograft), or synthetic materials or a combination thereof. CTPs can help encourage tissue repair or regeneration by providing scaffolds and the cells necessary to stimulate wound healing. Synthetic products may provide advantages over human or other animal sourced products because they are natural, non-biologic, avoid complications due to risk of disease transmission, and possess less immunologic potential.
The fully synthetic skin substitute evaluated in this study is SUPRA SDRM® Synthetic Biodegradable Matrix Wound Dressing (Polymedics Innovations Inc.; Woodstock,GA). The device is a novel synthetic, guided wound closure matrix, built as a bimodal foam membrane structure for the management of chronic wounds. It combines the benefits of a microporous structure that builds a protective barrier allowing the wound to heal and additional large pores which were created to enable ingrowth of blood vessels. This microenvironment initially provides a seal against contamination and modulates inflammation in wound bed. Subsequently, it supports cellular processes required for tissue repair and wound healing.
In this parallel randomized clinical trial, patients with diabetic foot ulcers grade UT 1A will receive either standard of care plus SUPRA SDRM or a collagen dressing (Fibracol Plus) weekly after wound debridement. Primary outcomes will be time to achieve wound healing, and the proportion of patients achieving healing by 12 weeks. Secondary outcomes will include the direct costs of treatment and the proportion of patients who developed infections during the trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Males and females aged 18 or older.
- •Subject is willing to sign an informed consent and participate in all procedures and follow-up evaluations.
- •Study ulcer is diabetic in origin, located on foot or below the malleolus (UT Grade 1A).
- •Study ulcer size is a minimum of 2 cm2 and a maximum of 25 cm
- •Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old.
- •Study ulcer has been offloaded for at least 14 days before randomization.
- •Subject does not exhibit clinical signs or symptoms of infection.
- •Subject has adequate control of diabetes demonstrated by Hemoglobin A1c < 12% within 90 days of screening.
- •Subject has adequate circulation to the affected extremity.
排除标准
- •Study ulcer has > 40% wound healing during the 14 days screening period.
- •Subject has a known history of poor compliance with medical treatments.
- •Subject is presently participating in another clinical trial.
- •Subject has a known or suspected local or systemic malignancy.
- •Subject has been diagnosed with autoimmune connective tissues diseases.
- •Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days.
- •Subject has received application of topical steroids on the study ulcer surface within the previous 30 days.
- •Subject is pregnant or breast feeding.
- •Subject is on dialysis.
- •Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies.
- •Subject cannot be on systemic antibiotics prior to randomization, however, during the treatment phase infection management may include systemic antibiotics if in conjunction with debridement.
- •Subject has a known allergy to ingredients/components of Supra SDRM®.
- •Subject has osteomyelitis, and/or bony prominences present in the wound.
- •Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).
- •Subject is unable to comply with planned study procedures and treatments.
结局指标
主要结局
Time to heal
时间窗: Up to 30 weeks
Number of weeks required to achieve 100% epithelization of the wound
Healing by 12 weeks
时间窗: 12 weeks
Proportion of patients achieving 100% epithelization on or before week 12
次要结局
- Infection rate(Up to 30 weeks)
- Direct costs(Up to 30 weeks)