Autologous Platelet-Rich Plasma Versus Conventional Dressing Method in the Treatment of Chronic Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- size of the ulcer reduce to zero cm
研究概览
简要总结
In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.
详细描述
The term "chronic wound" was first used in literature in the 1950s to refer to wounds that were difficult to heal or did not follow a normal healing process. However, the term has met criticism for its uncertainty regarding the duration of chronicity. Martin & Nunan, 2015, defined a "chronic wound" as a barrier defect that has not healed in 3 months, and Leaper & Durani, 2008, defined it as a wound that lacks a 20-40% reduction in its size after 2-4 weeks of optimal treatment or when there is no complete healing after 6 weeks. Recent reviews have highlighted the lack of consensus regarding the definition of a "chronic wound" and the need for further researches in this area.
Diabetic foot ulcer is a major complication of diabetes mellitus and is the major component of diabetic foot syndrome. This medical condition affects 15% of all patients with diabetes mellitus. Alvarsson et al. in 2012 reported that up to 88% of all lower leg amputations were related to diabetic foot ulcers.
The impact of chronic wounds on the health and quality of patients' life and their families should not be underestimated. Patients with chronic wounds may experience chronic pain, loss of function and mobility, depression, and anxiety, increased social stress and isolation, prolonged hospitalization, increased financial burden, and increased morbidity and mortality.
Growth factors (GFs) play an essential role in the process of wound healing and tissue regeneration. Each GF has more than one effect on the healing process and acts by binding to specific cell membrane receptors on the target cells. Growth factors' effects include promoting chemotaxis, inducing cell migration and proliferation, and stimulate cells to upregulate protein production. These growth factors not only regulate cell migration and proliferation but also promote angiogenesis and remodel the extracellular matrix, creating an ideal environment that favors the cutaneous wound healing process.
Over the last decades, the use of emerging cellular therapies, such as platelet-rich plasma (PRP), has more attention in a variety of diseases and settings for its potential use in the regenerative medicine as a therapeutic agent and can have an adjunctive role in a standardized, quality treatment plan.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic diabetic foot ulcers more than 1 cm in diameter that failed to heal in three months after wound debridement and dressing by a surgeon.
排除标准
- •Patients with evident local infection or gangrene (no redness, no hotness, no purulent discharge, no osteomyelitis in X-ray with a negative probe to bone test, and negative C-reactive protein).
- •Patients with end-stage organ failure, hepatic, or renal failure.
- •Patients on anticoagulants.
- •Patients on antiplatelet agents.
- •Patients with thrombocytopenia.
- •Patients on steroid therapy.
- •Ulcers less than 1cm or greater than 8 cm in diameter.
- •Deep ulcers more than 2 cm in depth.
- •Patients with lower limb ischemia (acute or chronic). Limb ischemia was excluded by the detection of the distal limb pulsations with ankle-brachial index>0.9.
结局指标
主要结局
size of the ulcer reduce to zero cm
时间窗: 20 weeks
complete coverage of the ulcer base by healthy tissue
次要结局
未报告次要终点
研究者
Yasser Ali Orban
principal investigator
Zagazig University