Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds Receiving Care in Diagnostic and Treatment Center From Regional Hospital of Talca
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- allergenic to propolis analysis
研究概览
简要总结
The general objective of the project is "To evaluate the effect of the administration of propolis extract as a coadjuvant in the treatment of diabetic foot ulcers in patients receiving cures in the Specialties Polyclinic of the Regional Hospital of Talca, Maule Region", which will be used Propolis produced in the area, (Laboratorios Rotterdam Ltda.) used in topical form.
It has been described that among the benefits produced by Propolis, is its anti-inflammatory, antioxidant effect and that the topical application of it is well tolerated, improving the healing of human diabetic foot ulcer.
详细描述
They will be invited to enter the study, at no cost, to 72 patients seen in the Specialty Clinic of the Regional Hospital of Talca, who have a history of diabetic feet with ulcers and who are in treatment with cures and who meet the following criteria. inclusion:
- People with Diabetes Mellitus (DM), older than 18 years, type 1 or 2, with known evolution of their diabetes between 2 and 15 years.
- Carriers of diabetic foot ulcers
- Without other important diseases
Patients who present the following criteria will be excluded from the study:
- Propolis allergy
- Serious circulation problems
- Foot burns
- Psychological conditions, or distances that prevent regular attendance to all required cures.
According to the programmed, 72 people will be admitted to the study, of which half will receive Propolis application on their wound at the end of their usual healing, for a maximum period of 75 days; while the other half will maintain the usual cure without Propolis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •DM type 1 or 2 with complicated foot diabetics wounds.
- •18-80 years old
排除标准
- •Propolis allergy
- •Critical ischemia
- •Severe infection
- •Psycho-social conditions that avoid regular attendance at health aid.
研究组 & 干预措施
Propolis group
The patients receive propolis (3% in Propylene Glycol) in all the wound surface in each healing until cicatrisation or at least 8 weeks. (n=20)
干预措施: Propolis spray (Drug)
结局指标
主要结局
allergenic to propolis analysis
时间窗: through study completion, with an average of 8 months
All patients were analyzed for the probability of allergenic reaction. It was done on the dermal reaction compared to the reaction to a single dose of histamine.
次要结局
- obtaining biopses(the first biopses was obtained at time zero of enrollment and every 4 weeks, until the wound close or at time 12 weeks (end point of the biopses obtaining))
研究者
Jessica Zuñiga-Hernandez
Head Laboratory, Unidad de Farmacología, Laboratorio de Investigaciones Médicas, Escuela de Medicina,
University of Talca