EUCTR2010-020513-87-IT
进行中(未招募)
不适用
A randomized, placebo-controlled, double-blind study on the intensity and duration of efficacy of sodium hyaluronate therapy (500-730 KDa) (HYALGAN) in the conservative treatment of Achilles tendinopathy. - ND
FIDIA0 个研究点2010年8月23日
相关药物HYALGAN
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- FIDIA
- 状态
- 进行中(未招募)
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Aged 18 to 70 years, inclusive; \- Diagnosis of chronic (symptoms persisting for over 6 weeks) or subacute (symptoms persisting for approximately 3\-6 weeks) tendinitis of the Achilles tendon, diagnosed clinically and/or by means of ultrasound; \- Pain in the Achilles tendon at rest or after moderate physical activity; \- Presence of at least one of the following parameters: ? swelling of the tendon, ? increase in local temperature (to the touch), ? pain upon touching or applying pressure, ? limited range of joint motion; \- Total score on VISA\-A less than 60; \- Non responder to traditional tendinitis therapy: anti\-inflammatory and/or physical therapy; \- Non\-responder to abstinence from the physical activity causing pain to the Achilles tendon; \- Signing of informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
排除标准
- •\- Tendinitis in acute inflammatory phase; \- Lateral instability of the ankle; \- Obesity: BMI \>35 kg/m2; \- Bilateral tendinitis; \- History of diabetes mellitus or any other disease which in the Investigator\`s opinion might influence the experimental data; \- Presence of areas of degeneration in the tendon (tendinosis); \- History of arthritic and/or metabolic disease; \- Suspected (based on clinical judgement or tests) structural lesions of the tendon (previous or current); \- Previous major trauma to the Achilles tendon; \- Previous surgery on the Achilles tendon under evaluation or on the same ankle; \- Oral, parenteral or intra\-articular use of corticosteroids during the three months previous to enrolment in the study; \- Infiltration therapy with hyaluronic acid on the Achilles tendon under evaluation during the three months previous to enrolment in the study; \- Para\-tendinopathy; \- Pregnancy; \- Participation in other clinical trials during the three months previous to enrolment in the study.
结局指标
主要结局
未指定
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