Comparative, Randomised, Double-blind, Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.
研究概览
简要总结
Randomised, double-blind, cost-effectiveness clinical trial of two 10% urea creams purchased in pharmacies and supermarkets in patients with diabetic foot syndrome.
详细描述
The aim of this study was to evaluate the cost-effectiveness of two 10% urea creams in patients with Diabetic Foot Syndrome.
The methodology was a prospective, longitudinal, single-centre, randomised, double-blind, longitudinal clinical trial that evaluated the skin quality of 20 participating feet belonging to 10 patients with Diabetic Foot Syndrome after the application of two 10% urea creams purchased in pharmacies and supermarkets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years with Diabetic Foot Syndrome
- •Deep or superficial sensory neurological involvement diagnosed by Semmes-Weinstein Monofilament and Rydel-Seiffer tuning fork
- •ABI (Ankle Brachial Index) in normal range
- •Metabolic Syndrome
- •No cognitive impairment
- •Patients who agreed to be included in the study by signing a written consent
排除标准
- •Patients with hypersensitivity or allergy to any of the components of both creams.
研究组 & 干预措施
Pharmacy cream 10% urea
Use of pharmacy cream in prevention
干预措施: Participants were given the 10% urea cream purchased in pharmacy or supermarket as appropriate after randomisation and their foot skin quality was assessed by validated questionnaire. (Other)
Supermarket cream 10% urea
Use of supermarket cream in prevention
干预措施: Participants were given the 10% urea cream purchased in pharmacy or supermarket as appropriate after randomisation and their foot skin quality was assessed by validated questionnaire. (Other)
结局指标
主要结局
Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.
时间窗: 5 months
The cost analysis will be carried out considering the price per ml of 10% urea cream used by the participants during their participation in the study.
Assessment of the skin quality of participants' feet before and after the cream application intervention using a validated questionnaire.
时间窗: 5 months
The assessment of skin quality was carried out using the "Questionnaire for assessment of injury risk and skin quality in patients with diabetic foot syndrome", validated intra-observer and inter-observer by this research group. The minimum score assigned in this questionnaire is 0 points and the maximum score is 12, with higher scores correlating with higher risk of injury and poorer skin quality of the feet.
次要结局
未报告次要终点
研究者
Jose Luis Lazaro Martinez
Prof. Dr.
Universidad Complutense de Madrid