Effect of the Use of Therapeutic Low-intensity 660 nm LASER in the Treatment of Diabetic Ulcers: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in complete ulcer healing
研究概览
简要总结
Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Diabetes mellitus has gained increasing importance and is considered one of the main themes of global health problems due to the damage caused to quality of life, public health and the epidemiological picture presented. Among the complications are diabetic foot ulcers, with higher prevalence in the lower limbs, they are classified as loss of skin continuity, which can reach from the epidermis to deep structures such as muscles, bones and tendons.
详细描述
100 volunteers will be recruited and the research will be carried out through the Integrated Center of Medical Specialties (CIEM) - Polyclinic, through referral from the specialist in vascular surgery after a thorough examination of the feet. Volunteers of both sexes, aged over 18 years, DM and diabetic ulcers will be admitted. Volunteers who present any autoimmune disease, concomitant psychiatric disorders or contraindications to the treatment methods adopted by the research will be excluded. Inclusion in the study will take place after signing the informed consent forms, after approval by the Ethics Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 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
- •Type 2 diabetes mellitus patients with diabetic foot ulcers;
- •Patients aged 18 and over.
排除标准
- •Patients with autoimmune diseases
- •Patients with concomitant psychiatric disorders
- •Patients with contraindications to treatment methods
- •Patients with infected diabetic foot ulcers.
研究组 & 干预措施
Comparador de placebo: CC + curativo
The group will receive placebo LASER application associated with Helianthus annuus oil dressing.
干预措施: Dressing (Procedure)
Comparador ativo: LG2 + curativo
The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing.
干预措施: LG2 (Device)
Comparador ativo: LG2 + curativo
The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing.
干预措施: Dressing (Procedure)
Comparador ativo: LG1 + curativo
The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing.
干预措施: LG1 (Device)
Comparador ativo: LG1 + curativo
The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing.
干预措施: Dressing (Procedure)
Comparador ativo: LG3 + curativo
The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing.
干预措施: LG3 (Device)
Comparador ativo: LG3 + curativo
The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing.
干预措施: Dressing (Procedure)
结局指标
主要结局
Change in complete ulcer healing
时间窗: Before intervention starts, 5th and 10th week of intervention.
Change in the percentage of complete ulcer healing.
Change in the ulcer area
时间窗: Before intervention starts, 5th and 10th week of intervention.
Measure of ulcer area change.
次要结局
未报告次要终点
研究者
Vinicius Saura Cardoso
principal investigator
Federal University of Piaui