CTRI/2024/03/064567尚未招募3 期
A case study to evaluate the efficacy and safety of TendoshotPro in Tendon Injury (Knee Sprain, Ankle Sprain (AchillesHeel), Shoulder Dislocation, Post-Operative Recovery, Plantarfasciitis) Patients of Grade 2 - NI
Innovcare LifeSciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female patients aged more than 18 years with
- •grade 1 and 2 Tendon Injury of knee, ankle or shoulder –
- •with or without dislocation.
- •2. Pain defined by a level of greater than or equal to 30 mm
- •on a 100 mm Visual Analogue Scale (VAS)
- •3. Patient should have not participated in any other clinical
- •trial during the past 3 months.
- •4. Participants, who are willing to give written, signed and
- •dated informed consent to participate in the study.
排除标准
- •1. Prior knee/ankle /shoulder surgery;
- •2. Torn or avulsed tendon;
- •3. Periarticular or long bone fracture that is
- •anticipated to preclude weight-bearing after surgery;
- •4. Require use of an external fixator for greater than 10 days;
- •5. Planned staged surgical treatment;
- •6. Unable to weight bear on the contralateral uninjured leg;
- •7. Traumatic brain injury (TBI) that limits their ability to
- •participate in their post-operative care;
- •8. Any condition that would preclude the ability to comply with
- •post-operative guidelines
- •9. Moderate to severe renal impairment
- •10. Pregnant or lactating
- •11. History of hypersensitivity to any of the test products.
- •12. Any condition decided as unfit for study by Clinical
- •investigator
研究者
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