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Not yet recruiting NCT07693556

Collagenase Injection for Contracture Management

Early Phase I Interventional Contracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active XIAFLEX Collagenase injection.
Who it may be relevant to
Registry conditions: Contracture. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Collagenase Injection for Contracture and Spasticity Management

Overview

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.

Interventions

  • Biological Active XIAFLEX Collagenase injection
    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 patie

Primary outcome measures

  • 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]
  • Safety as assessed by the number of adverse events [Time frame: From baseline to end of study (3 months post-injections)]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
  • clinical diagnosis of tendon contracture

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07693556 · HSC-MS-25-0499 (Experiment 2)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗