DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Time to Complete Wound Healing
研究概览
简要总结
The purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of a chronic plantar foot ulcer in subjects with diabetes mellitus. For the purpose of this study, the definition of plantar foot ulcer is a wound or open sore that involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration of 6 weeks or greater with a lack of response to treatment.
详细描述
Diabetic foot complications are the most common cause of nontraumatic lower extremity amputations in the industrialized world. The risk of lower extremity amputation ranges from 15 to 46 times higher in diabetics than in persons who do not have diabetes mellitus. Furthermore, foot complications are the most frequent reason for hospitalization in patients with diabetes, accounting for up to 25 percent of all diabetic admissions in the United States and Great Britain. The vast majority of diabetic foot complications resulting in amputation begin with the formation of skin ulcers. Early detection and appropriate treatment of these ulcers may prevent up to 85 percent of amputations. (Armstrong)
The primary goal in the treatment of diabetic foot ulcers is to obtain wound closure. Rest, elevation of the affected foot, and relief of pressure are basic treatments that are usually initiated when the patient first presents with a foot ulcer. A postoperative shoe or another type of pressure-relieving footwear is also often prescribed. Crutches or a wheelchair might also be recommended to totally off-load pressure from the foot. Necrotic tissue is debrided to allow full visualization of the extent of the ulcer, to allow detect underlying abscesses or sinuses, and to support healing. Wet-to-wet dressings are used to provide a warm, moist environment that is protected from external contamination is most conducive to wound healing. Additional options include numerous topical medications and gels, and special dressings, including semipermeable films, foams, hydrocolloids, and calcium alginate swabs.
When these more conservative treatments fail, another recently developed nonoperative option is available. The genetically engineered platelet-derived growth factor becaplermin (Regranex Gel, OMJ Pharmaceuticals, Inc.) is approved for use on neuropathic diabetic foot ulcers and can expedite healing. Growth factors stimulate chemotaxis and mitogenesis of neutrophils, fibroblasts, and monocytes, as well as other components that form the cellular basis of wound healing.
When nonoperative treatments fail, skin grafting is often required to achieve wound closure. In addition to autologous donor tissue for the graft procedure, bioengineered skin (Apligraf, Organogenesis, P950032/S016) and human dermis (Dermagraft, Smith & Nephew, P000036) are new types of biologically active implants approved for diabetic foot ulcers that are derived from fibroblasts of neonatal foreskins. These bioengineered products enhance healing by acting as delivery systems for growth factors and extracellular matrix components through the activity of live human fibroblasts contained in their dermal elements. (Frykberg)
Despite the variety of modalities available to treat diabetic foot ulcers, the US Center for Disease Control reports that the age-adjusted lower extremity amputation rate for persons with diabetes is 5.5 per 1,000 persons with diabetes, which is was 28 times that of persons without diabetes.
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
- •Diagnosis of a single chronic plantar foot ulcer that has persisted for a minimum of 6 weeks duration
- •History of Type 2 diabetes mellitus; (track/ask if insulin dependent)
- •Capable of wound care at home;
- •The ulcer measures > 1 cm and <4 cm at any dimension
- •The ulcer is Stage 1 or 2A according to the classification system described by Lavery et al.
- •Stage 1 - superficial wounds through the epidemis or epidermis and dermis that did not penetrate to tendon, capsule or bone.
- •Stage 2A - Clean wounds that penetrated to tendon or capsule.
- •Palpable pedal pulse in the affected leg OR peripheral vascular disease evaluation demonstrating acceptable blood supply to affected foot;
- •Subjects age > 18 years;
- •The Investigator has completed a medical history and a physical examination to assure that the subject meets all study enrollment criteria;
- •The subject is willing and able to read, understand and sign the study specific informed consent form; and
- •The subject agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the wound (e.g., wet to wet dressings, orthotics) and all follow up visit requirements.
排除标准
- •Pregnancy
- •Type I diabetes
- •Plantar foot ulcer extends to and /or involves the bone or joint;
- •Ulcers are present on both feet
- •Multiple ulcers on the foot
- •Clinical evidence of cellulitis at the ulcer site or surrounding area;
- •Ulcers that have purulent exudates or malodorous exudates on visual examination
- •Diagnosis of a chronic plantar foot ulcer that has persisted for >1 year.
- •Peripheral vascular disease per the study enrollment work-up requiring vascular surgery intervention.
- •ABI (Ankle Brachial Index) < 0.6 Ulcer debridement under anesthesia in OR required within the 2 week observation phase,
- •Lower extremity revascularization procedure (e.g. PTA, graft, etc.) within eight (8) weeks of the study screening visit.
- •Uncorrected biomechanical abnormalities that cause or contribute to the affected lower extremity ulcer; (e.g. tight Achilles tendon, hammer toe, Charcot foot etc.)
- •Surgical procedure to correct biomechanical abnormities (e.g., lengthening of the Achilles tendon. correction of hammer toe, Charcot foot correction) within eight (8) weeks of the study screening visit;
- •Deep vein thrombosis within 6 months of study screening visit;
- •Clinical evidence of lymphadema;
- •Active or previous (within 60 days prior to the study screening visit) chemotherapy;
- •Treatment of the plantar foot ulcer with growth factors, prostaglandin therapy or vasodilator therapy during the 2 week observation phase.
- •Subject on steroid therapy
- •Sickle cell anemia
- •Infection with Human Immunodeficiency Virus
- •Immunodeficiency disorders
- •Severe protein malnutrition - serum albumin < 2.0g/dl
- •Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females)
- •Recent treatment (within 60 days prior to the study screening visit) with immunosuppresants, radiation, or biologically active cellular / acellular products;
- •Current history of substance abuse.
- •Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits;
- •Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment; or
- •The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
结局指标
主要结局
Time to Complete Wound Healing
次要结局
- o Durability of wound closure (i.e., status of wound at one week following determination of "healed")
- o Results of quantitative wound cultures (Ulcers with a quantitative wound culture with a bacterial count greater than 105 per gram of tissue will be defined as an infected ulcer);
- o The percentage of the wound that has healed
- o A comparison of the total number of subjects with a final status of "Healed" in the active versus control group
- o Partial healing at 12 weeks post treatment ((size of wound compared to baseline));
- o The number of shock wave treatments performed