ContractureEarly Phase 1NCT07693556
Collagenase Injection for Contracture Management
A Early Phase 1 study testing Active XIAFLEX Collagenase injection in people with Contracture, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for contracture management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Contracture
- What is being tested?
- Active XIAFLEX Collagenase injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Sep 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
- clinical diagnosis of tendon contracture
Who cannot join
- Is hypersensitive to XIAFLEX or collagenase;
- Is currently adjusting tone alternating medications (e.g., baclofen), or
- Received botulinum toxin injection to target areas <4 months, or phenol injections < 9 months;
- Received surgical release of tendons;
- Is a pregnant woman;
- Has coagulation disorders, including those who receive concomitant anticoagulants (except for low-dose aspirin).
- has heritable connective tissue disorders, including those within the Ehlers-Danlos syndrome (EDS) spectrum.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Collagenase Injection for Contracture and Spasticity Management
The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for contracture management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury.
- Conditions
- Contracture
- Being tested
- Active XIAFLEX Collagenase injection
- Medical subject headings
- Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active XIAFLEX Collagenase injectionBiological
Collagenase is an enzyme that breaks down collagen, which is a key component of connective tissue, such as fascia. XIAFLEX is an FDA-Approved collagenase for treatment of Dupuytren's contracture with a palpable cord in the fingers, and Peyronie's disease in the penile tissue. In this research project, we plan to use collagenase to treat contracture in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury. FDA guidelines will be followed for dosing and patient selection to minimize or reduce the risks.
| Study group | Role | What they receive |
|---|---|---|
| Active XIAFLEX Collagenase injection | Experimental | Not described Receives: Biological: Active XIAFLEX Collagenase injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spasticity as assessed by the Modified Ashworth Scale (MAS)
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.
Measured: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
Safety as assessed by the number of adverse events
Adverse events include
- 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.
- XIAFLEX injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.
Measured: From baseline to end of study (3 months post-injections)
Secondary outcomes (2)
Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM)
Range of motion (ROM) refers to the degree of movement available at a joint, measured in degrees using a goniometer. For PROM, the examiner will move the joint to its maximal pain-free range. Measurements will be recorded in degrees, and higher values indicate greater joint mobility.
Measured: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
Change in range of motion of target joints as assessed by the Active Range of Motion (AROM)
Range of motion (ROM) refers to the degree of movement available at a joint, measured in degrees using a goniometer. For AROM, participants will be instructed to move the joint as far as possible without assistance. Measurements will be recorded in degrees, and higher values indicate greater joint mobility.
Measured: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693556
- Sponsor's protocol ID
- HSC-MS-25-0499 (Experiment 2)
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagenase Injection for Contracture and Spasticity Management
- ClinicalTrials.gov ID
- NCT07693556
- Acronym / sponsor ID
- HSC-MS-25-0499 (Experiment 2)
- Conditions
- Contracture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for contracture management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active XIAFLEX Collagenase injection | Experimental | Biological: Active XIAFLEX Collagenase injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
- clinical diagnosis of tendon contracture
Key exclusion criteria (7 listed)
- Is hypersensitive to XIAFLEX or collagenase;
- Is currently adjusting tone alternating medications (e.g., baclofen), or
- Received botulinum toxin injection to target areas <4 months, or phenol injections < 9 months;
- Received surgical release of tendons;
- Is a pregnant woman;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active XIAFLEX Collagenase injectionCollagenase is an enzyme that breaks down collagen, which is a key component of connective tissue, such as fascia. XIAFLEX is an FDA-Approved collagenase for treatment of Dupuytren's contracture with a palpable cord in the fingers, and Peyronie's disease in the penile tissue. In this research project, we plan to use collagenase to treat contracture in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury. FDA guidelines will be followed for dosing and patient selection to minimize or reduce the risks. | Biological | Active XIAFLEX Collagenase injection |
Primary outcome
Change in spasticity as assessed by the Modified Ashworth Scale (MAS)
Time frame: 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 events
Time frame: From 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.
2 secondary outcomes
Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM)
Time frame: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
Change in range of motion of target joints as assessed by the Active Range of Motion (AROM)
Time frame: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng Li, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Active XIAFLEX Collagenase injection in people with Contracture, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Li, MD, PhD ((713) 797-7125, sheng.li@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spasticity as assessed by the Modified Ashworth Scale (MAS) (time frame: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.