Anterior Talofibular Ligament InjuryNCT06826898
To Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
A study testing DEFEHERE Absorbable Adhesion Barrier in people with Anterior Talofibular Ligament Injury, run by Talent Cro Inc. at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Talofibular Ligament Injury
- What is being tested?
- DEFEHERE Absorbable Adhesion Barrier
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2025to 30 Jun 2026
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol.
Who cannot join
- 2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua
Yan-Yu Chen doctor, +88647684326, swallowfish@gmail.com
About this study
Official title: A Prospective, Single-center, Randomized, Evaluator/subject-blinded, Controlled Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
The goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.
- Conditions
- Anterior Talofibular Ligament Injury
- Being tested
- DEFEHERE Absorbable Adhesion Barrier, Sham (No Treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEFEHERE Absorbable Adhesion BarrierDevice
DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
Sham (No Treatment)Device
conventional therapy without using any antiadhesion product
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Adhesion Barrier | Experimental | DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe Receives: Device: DEFEHERE Absorbable Adhesion Barrier |
| Sham | Sham comparator | conventional therapy without using any antiadhesion product Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
Measured: day 14
Secondary outcomes (7)
Range of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
Measured: baseline, day 28, 49, 70
Anterior Talar Translation (ATT)
On the sagittal plane, the talus below the tibia will be pulled forward to test the integrity of the anterior talofibular ligament.
Measured: baseline, day 14, 28, 49, 70
Visual Analogue Scale (VAS) for pain
The VAS scale uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'
Measured: baseline, day 14, 28, 49, 70
Cumberland Ankle Instability Tool (CAIT) questionnaire
The Cumberland Ankle Instability Tool (CAIT) is a 9-item 30-point scale that measures the severity of functional ankle instability.
Measured: baseline, day 14, 28, 49, 70
American Orthopedic Foot and Ankle Society (AOFAS) questionnaire
AOFAS includes 9 items that can be divided into three subscales (pain, function and alignment).
Measured: baseline, day 14, 28, 49, 70
Foot and Ankle Ability Measure (FAAM) questionnaire
A self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The FAAM is a 31-item questionnaire divided into two subscales: Activities of Daily Living Subscale and Sports Subscale.
Measured: baseline, day 14, 28, 49, 70
Subject self-assessment satisfaction scores
Subject self-assessment satisfaction scores
Measured: day 14, 28, 49, 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Talofibular Ligament InjuryStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talent Cro Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826898
- Sponsor's protocol ID
- RDCT-SCDH
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Evaluator/subject-blinded, Controlled Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
- ClinicalTrials.gov ID
- NCT06826898
- Acronym / sponsor ID
- RDCT-SCDH
- Conditions
- Anterior Talofibular Ligament Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Talent Cro Inc.University, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Feb 2025 (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 goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable Adhesion Barrier | Experimental | Device: DEFEHERE Absorbable Adhesion BarrierDEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe |
| Sham | Sham comparator | Device: Sham (No Treatment)conventional therapy without using any antiadhesion product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol.
Key exclusion criteria (1 listed)
- 2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.
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 |
|---|---|---|
| DEFEHERE Absorbable Adhesion BarrierDEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe | Device | Absorbable Adhesion Barrier |
| Sham (No Treatment)conventional therapy without using any antiadhesion product | Device | Sham |
Primary outcome
Range of Motion (ROM)
Time frame: day 14
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
7 secondary outcomes
Range of Motion (ROM)
Time frame: baseline, day 28, 49, 70
Anterior Talar Translation (ATT)
Time frame: baseline, day 14, 28, 49, 70
Visual Analogue Scale (VAS) for pain
Time frame: baseline, day 14, 28, 49, 70
Cumberland Ankle Instability Tool (CAIT) questionnaire
Time frame: baseline, day 14, 28, 49, 70
American Orthopedic Foot and Ankle Society (AOFAS) questionnaire
Time frame: baseline, day 14, 28, 49, 70
Foot and Ankle Ability Measure (FAAM) questionnaire
Time frame: baseline, day 14, 28, 49, 70
Subject self-assessment satisfaction scores
Time frame: day 14, 28, 49, 70
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 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
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BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
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Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEFEHERE Absorbable Adhesion Barrier in people with Anterior Talofibular Ligament Injury, run by Talent Cro Inc. at 1 site in Taiwan.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yan-Yu Chen Doctor (+88647684326, swallowfish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) (time frame: day 14). 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 14 Feb 2025.