Effect of the Rich Plasma in Growth Factors on the Cicatrization of Diabetic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Changing the dimensions of the ulcer area
研究概览
简要总结
Diabetic foot is defined by World Health Organization as a syndrome in which the presence of neuropathy, ischemia and infection cause tissue damage or ulcers from minor trauma. This condition can be controlled in its early stages with conservative treatment, which is effective in preventing infections and amputations. However, even with the new knowledge acquired and the development of new therapies, the specialist often faces wounds that do not improve despite the proper treatment, so therapies have been sought to help the healing of these Ulcers. Growing evidence suggests that healing of chronic diabetic foot ulcers depends on growth factors and that the therapeutic use of these in wounds has the potential to accelerate their healing in conjunction with wound care Conventional. This study evaluates the effect of plasma rich in autologous growth factors on healing chronic ulcers of diabetic origin.
This is a randomized clinical trial that evaluates two study groups. Control group in which advanced weekly healing will be performed while the post-advanced healing study group will be performed the intradermal application of plasma rich in growth factors. These manoeuvres will be performed once a week for four weeks and at the end of the study the results in both groups will be checked. Both groups will also evaluate, frequency and intensity of pain, quality of life, histological changes in ulcers and metabolic evaluation
详细描述
The diabetic foot is a devastating complication of diabetes mellitus that is accompanied by chest-evolving ulcers, which often lead to amputation. Annually more than a million people lose some limb stake because of this cause. Foot ulceration is the most common complication of diabetic patients and is thought to affect up to 15% of them throughout their lives (8, 9).
Ulcers that do not progress over a period of approximately 4 weeks should be reassessed. Several studies have also shown that chronic ulcers in general and diabetic foot ulcers in particular have alterations in fibroblast proliferation, the balance between growth factors, metalloproteinase (MMP) and remodeling extracellular matrix (2, 8, 9).
Changes in matrix metalloproteinase levels, as well as Regulated on Activation , Normal T-cell Expressed and Secretated, interleukin and procalcitonin have been correlated with wound healing (10). Metalloproteinase and its regulators, matrix metalloproteinase tissue inhibitors (TIMPes) are necessary for a wound to be properly healed at an appropriate level, at the right location and for a precise period of time. These aspects, it is presumed, are not met in chronic wounds such as ulcers of diabetic origin (11).
Autologous growth factor-rich plasma (PRFC), applied at the wound site releases dozens of growth factors, chemokines and cytokines that regulate angiogenesis, epithelialization and regeneration (15, 16). They are secreted by the granules and has been found to contribute to increase the speed of the natural healing process with a decrease in time (4).
Platelet-rich plasma is defined as an autologous or allogeneic platelet derivative with a concentration of platelets higher than the baseline. Autologous growth factor-rich plasma (PRFC) is the fraction of plasma derived from autologous blood, which after being processed by centrifugation, has a higher concentration of platelets and higher than baseline growth factors (8). There are two obtaining techniques: closed and open. In the case of obtaining by "closed technique", the method used must follow the instructions described in the disposable kits used in each commercial system. The "open technique" allows, on the other hand, from lower blood volumes and simple equipment, to obtain a higher concentration of growth factors (25).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic ulcers of diabetic origin of more than 4 weeks of evolution in lower extremities with treatment with hypoglycemic and/or insulin.
- •Age over 18 years and under 75 years, both genders.
- •Platelet count greater than 100,000 platelets per mm
- •Serum Hb level of > 9 g/dl both genders and<18 g/dl in men and <16 g/dl in women.
- •HbA1c level <8%
- •Serum triglyceride level <300 mg/dl.
- •Grade IA and IIA ulcers according to Texas classification.
- •Dimension greater than 3 cm in any of its diameters.
- •Ankle-arm index >0.7.
排除标准
- •Chronic ulcers of traumatic, neoplastic, infectious, vascular and ischemic origin.
- •Evidence of malignant ulcer
- •Clinical evidence of ulcer infection at the start of treatment such as purulent secretion, local hyperthermia or active systemic infection.
- •Haematological or coagulation disturbances.
- •Carriers of syphilis, HIV, Hepatitis Virus B and C.
- •Chronic use of corticosteroids
结局指标
主要结局
Changing the dimensions of the ulcer area
时间窗: Up to four weeks
The area of the ulcers will be measured every week in both groups in square centimeters recording the change
次要结局
- Change in the major and minor diameters of ulcers(Up to four weeks)
- Change in pain intensity(Up to four weeks)
研究者
María Guadalupe de Lourdes González Avalos
Principal investigator
Universidad de Guanajuato