Topical Collagen-povidone Injection as an Alternative Treatment for Stenosing Tenosynovitis in Older Adults With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean evolution time of tenosynovitis
研究概览
简要总结
Diabetes affects 415 million adults globally, leading to hand issues. Povidone collagen shows promise in managing tenosynovitis. A clinical trial was conduced to compared its efficacy in adults over 60. It is shown that the intervention reduces pain, improves functionality, and grip strength with no complications. Collagen povidone holds potential for treating diabetic hand issues.
详细描述
A randomized clinical trial from January 2022 to January 2023 compared povidone collagen intervention with a placebo in adults aged 60 and above suffering from stenosing tenosynovitis. Participants were randomized into Case (collagen-povidone) and Control (physiological solution) groups. The study evaluated parameters like tenosynovitis, diabetes, pain, functionality, and grip strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single-blind
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic of stenosing tenosynovitis
- •Diagnostic of diabetes
- •Adults aged 60 or older
排除标准
- •Adults aged 60 or older
研究组 & 干预措施
Therapeutic intervention using povidone collagen
干预措施: collagen-povidone solution (Drug)
Therapeutic intervention using placebo
干预措施: collagen-povidone solution (Drug)
结局指标
主要结局
Mean evolution time of tenosynovitis
时间窗: 12 months
Tenosynovitis should decreased its progression in the experimental group
次要结局
未报告次要终点
研究者
GONZALEZ-OJEDA ALEJANDRO
Principal Investigator
Instituto Mexicano del Seguro Social