Double Blind, Randomized, Placebo Controlled Clinical Trial for the Treatment of Diabetic Foot Ulcers, Using a Nitric Oxide Releasing Patch: PATHON
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ulcer reduction percentage
研究概览
简要总结
Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-traumatic amputation of inferior limbs. It is estimated that 15% of diabetic population will develop an ulcer sometime in their life. Although novel therapies have been proposed, there is no effective treatment for this pathology. Naturally produced nitric oxide participates in the wound healing process by stimulating the synthesis of collagen, triggering the release of chemotactic cytokines, increasing blood vessels permeability, promoting angiogenic activity, stimulating the release of epidermal growth factors, and by interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical donors needed to be applied frequently, diminishing the adherence to the treatment. This difficulty has led to the development of a multilayer polymeric transdermal patch produced by electrospinning technique that guarantees a constant nitric oxide release. The main objective of this study is to evaluate the effectiveness and safety of this novel nitric oxide releasing wound dressing for the treatment of diabetic foot ulcers.
A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was designed. At the time of enrollment, a complete medical evaluation and laboratory tests will be performed, and those patients who meet the inclusion criteria randomly assigned to one of two groups. During 90 days group 1 will receive active patches and group 2 placebo patches. The patients will be seen by the research group at least every two weeks until the healing of the ulcer or the end of the treatment. During each visit the healing process of the ulcer, the patient's health status and the presence of adverse events will be assessed. Should the effectiveness of the patches be demonstrated an alternative treatment would then be available to patients.
详细描述
Background
Diabetes Mellitus (DM) constitutes one of the most important public health problems with a worldwide impact due to its high prevalence and enormous social and economic consequences. It is believed that there are more than 135 million diabetics, and this number is expected to increase to 300 million in the next 25 years (30% in developed and 70% in developing countries) [1;2].
This epidemic is related to several factors like ethnicity, the longer life expectancy, and the epidemiological and nutritional transition in developing countries due to the urbanization process that brings about obesity and sedentarism [3;4]. In Colombia, the 2002 basic health indicators showed a 2% prevalence of DM. However, it is believed that these numbers are underestimated [5]. Diabetic Foot Ulcers (DFU) are one of the chronic consequences of DM which constitute the most important cause of non-traumatic amputation of the Inferior Limbs (IL), and are associated with high human, social and economic costs [6-11]. It is estimated that approximately 15% of the diabetic population will develop a DFU some time in their life [12-16].
DFU is a consequence of two of the most frequent chronic complications of DM: Peripheral neuropathy and vascular insufficiency [12]. The combination of these factors in association with mechanic extrinsic and intrinsic aggressions, like feet bone deformations, triggers the ulcer formation. This polyfactorial etiopathology explains the multidisciplinary approach required for this disease [17-19].
The early detection of risk factors for DFU may prevent their appearance [20-28]. This is why the monitoring of neuropathic, vascular and muscle-skeletal functions [29], the reinforcement of self care [30], the control of glycemic levels and the prevention of traumatic foot lesions [31-34], have a positive impact on the prevention of this pathology.
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
- 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
- 否
入选标准
- •Men and women 18 years or older.
- •Capacity of attending the visits at the research site.
- •Confirmed diagnosis of DM type 1 or 2 according to the guidelines from the American Diabetes Association (ADA).
- •Presence of 1 or more DFU, less than 15cm in its biggest diameter, with a Texas University score ≤
- •Pharmacological treatment for glycemic control.
- •Willingness to participate in the study and to sign the informed consent form.
排除标准
- •Unconfirmed DM diagnosis.
- •Any pathology that, based on the judgment of the researcher, could alter the course of DFU (neoplasias, immunological disorders, etc).
- •Renal insufficiency requiring dialysis treatment.
- •DFU with a Texas score >
- •Infected DFU with clinical or paraclinical findings suggesting osteomyelitis.
- •Critical ischemia of IL diagnosed by Doppler ultrasound and defined by ankle/arm index < 0.
- •Clinical findings suggesting complicated venous insufficiency of IL.
- •Distal necrosis of the limb with the ulcer.
- •Pregnant or breastfeeding women.
- •Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
- •Refusal to give informed consent.
研究组 & 干预措施
1
Nitric oxide patches
干预措施: Controlled nitric oxide releasing patch (Drug)
2
Placebo patches
干预措施: placebo patch (Drug)
结局指标
主要结局
Ulcer reduction percentage
时间窗: 90 days after beggining the treatment
次要结局
- Complete cure of the infection that was present before the treatment.(during 90 days of treatment)
- Infection of the ulcers during the treatment.(during 90 days of treatment)
- Presence of adverse events related to the application of the patches(during 90 days of treatment)