Collagenase Injection for Contracture Management
This study is looking at how well Collagenase injection, specifically XIAFLEX, works to treat contractures (tightening of muscles or joints) in people who have had a stroke, brain injury, or spinal cord injury. XIAFLEX contains an enzyme that breaks down collagen, a material that can contribute to contractures. You might be able to join if you are 18 to 75 years old, have a clinical diagnosis of tendon contracture, and are at least six months past your stroke, brain injury, or spinal cord injury. The researchers will measure changes in muscle stiffness using a scale called the Modified Ashworth Scale (MAS) and track any side effects to see if the treatment is safe and effective. The study aims to enroll 15 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm study with a planned enrollment of 15 participants.
- What's involved
- You would receive Collagenase injections and have follow-up visits at 2 days, 2 weeks, 1 month, and 3 months after the injections.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and effectiveness for 3 months after the injections.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Collagenase Injection for Contracture Management
At a glance
Conditions
NCT07693556
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
The University of Texas Health Science Center at Houston
Houston, Texasno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sheng Li, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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Inclusion
Exclusion
What this trial measures
- Change in spasticity as assessed by the Modified Ashworth Scale (MAS)Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
The Modified Ashworth Scale (MAS) evaluates the increase in muscle tone associated with upper motor neuron lesions. MAS scores will be recorded for the target muscle group(s) at each assessment time point.Scores range from 0 to 4, with an additional grade of 1+ between 1 and 2. Scores are defined as: 0 = no increase in muscle tone; 1 = slight increase in muscle tone with a catch and release or minimal resistance at the end of the range of motion; 1+ = slight increase in muscle tone with a catch followed by minimal resistance through less than half of the range of motion; 2 = more marked increase in muscle tone through most of the range of motion, but the affected part is easily moved; 3 = considerable increase in muscle tone, passive movement difficult; 4 = affected part rigid in flexion or extension.Lower MAS scores indicate reduced spasticity and improved muscle tone, whereas higher scores indicate greater spasticity.
- Safety as assessed by the number of adverse eventsFrom baseline to end of study (3 months post-injections)
Adverse events include 1. Serious complications of XIAFLEX injection include tendon rupture, serious ligament damage, or skin laceration that may result in the inability to fully bend the joint and may require surgery to correct the complication. 2. XIAFLEX injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.