Ankle FractureNCT06863688
Ankle Fracture Tourniquet Utilization
A study testing Tourniquet and No Tourniquet in people with Ankle Fracture, run by Alex Demers at 1 site in United States.
Trial summary
Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- Tourniquet and No Tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2024to 30 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 y.o. undergoing ankle fracture open reduction internal fixation
- Ground level fall as mechanism of injury
- Closed injury
Who cannot join
- Open Ankle Fractures
- Vascular Injury Requiring Intervention
- Lower extremity injuries on same side of ankle fracture
- Active anticoagulation/bleeding disorder necessitating tourniquet use (Hemoglobin <7, PT >13, PTT>35) f) Ipsilateral lower extremity trauma impacting immobilization g) Patients with peripheral neuropathy h) Patients undergoing ankle arthroscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Does Tourniquet Utilization Negatively Impact Patient Pain and Outcomes Following Operative Fixation of Rotational Ankle Fractures? A Randomized Clinical Trial.
Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. Patients will be randomized by an Excel random number generator to a tourniquet and non-tourniquet group. Patients will remain blinded to randomization. The treating orthopaedic trauma surgeon will be notified by the PI of the study informing them of the randomization status to ensure appropriate tourniquet utilization the day of surgery. Patients will then undergo standard operative fixation and postoperative management as clinically indicated by the orthopaedic trauma team. Patients will follow-up at 2 weeks and subsequently every 4 weeks as is protocol at our institution. Patient charts will be reviewed for patient and perioperative factors, as well as postoperative complications (i.e. wound complications, need for repeat surgical intervention, and deep vein thrombosis).
Read the detailed description
Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. II.
Tourniquet utilization in the operative fixation of ankle fractures remains controversial and is often subject to surgeon preferences. Despite postulated benefits of minimizing blood loss, decreasing operative times, and improving visualization, tourniquets in ankle fracture fixation have been associated with increased postoperative pain, swelling, decreased range of motion, and increased opioid consumption. Previous literature has demonstrated a nonsignificant increase in wound infections and deep vein thrombosis (DVT) with tourniquet usage. Changes in perfusion intraoperatively and effects of ischemic reperfusion injury have been theorized as drivers of these negative side effects of tourniquets. Perfusion following ankle fracture fixation, thus represents an opportunity to better understand the physiologic implications of tourniquet utilization.
Tourniquet use is associated with negative outcomes after total knee arthroplasty (TKA). Despite decreased blood loss, tourniquet use in TKA has been associated with higher VAS pain scores, decreased knee range of motion and functional scores in the early postoperative period, higher rates of thrombotic events, infection, and reoperation. Impaired prosthesis survival, knee function, blood transfusion rates, quality of life, and patient satisfaction bring into question the utility of tourniquet use in TKA. These outcomes have not been thoroughly investigated in the fixation of ankle fractures.
- Conditions
- Ankle Fracture
- Being tested
- Tourniquet, No Tourniquet
- Keywords
- Ankle Fracture, Tourniquet, PROM, Pain
- Medical subject headings
- Ankle Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetDevice
Tourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures.
No TourniquetOther
No tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures.
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet Group | Experimental | Patients randomized to this group will have a tourniquet used during the operative fixation of their ankle fracture. Tourniquets will be inflated to 250 mmHg as is standard for our institution. Tourniquet will be deflated at time of closure. Receives: Device: Tourniquet |
| No Tourniquet Group | Other | Patients randomized to this group will not have a tourniquet used during operative fixation of their ankle fracture. A tourniquet will be placed on the patient's operative extremity as a safety precaution, but will remain deflated for the duration of the procedure unless emergently needed for hemostasis. Receives: Other: No Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Pain Levels
VAS pain scores (0-10) will be assessed for the ankle immediately postoperatively in the post anesthesia care unit and at 2 weeks, 6 weeks and 3 months postoperatively.
Measured: Post anesthesia recovery unit, 2 weeks postoperatively, 6 weeks, 3 month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores
Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V1.1 Pain Interference (10-90, lower is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.
Measured: 6 weeks, 3 months
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V2.0 Physical Function Score
Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V2.0 Physical Function (10-90, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.
Measured: 6 weeks, 3 month
Patient-Reported Outcome Measurement Information System (PROMIS) Scale V1.2 Global Health Score
Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Scale V1.2 Global Health (15-70, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.
Measured: 6 weeks, 3 months
Optimal Screening for Prediction of Referral and Outcome (OSPRO) Yellow Flag 17-Item
OSPRO-Yf 17 questionnaires will be completed at follow-up appointments as part of standard trauma clinic workflow and will be assessed at 6 weeks, and 3 months.
Measured: 6 weeks, 3 months
Secondary outcomes (1)
Postoperative Complications
Postoperative complications following operative fixation of ankle fractures will be assessed at follow-up appointments and through chart review. Complications include postoperative deep vein thrombosis, wound complications and infection (patients receiving antibiotics or requiring surgical irrigation and debridement), need for revision fixation or hardware removal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start24 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ankle FractureStudies 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
- Model description
- Patients undergoing operative fixation of ankle fractures will be randomized to the tourniquet and no tourniquet groups in a 1:1 fashion. The treating orthopaedic trauma surgeon will be informed of the randomization status the day of surgery by the PI to ensure appropriate tourniquet utilization is executed during surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alex Demers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alex Demers, University of Iowa
- Investigators
- Alex Demers, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863688
- Sponsor's protocol ID
- 202311372
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared secondary to data sharing regulations at our institution.
Publications
Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13.
PubMed 24602486Benedick A, Rivera T, Vallier HA. Effect of Tourniquet Use During Ankle Fracture Fixation on Wound Healing and Infectious Complications. Foot Ankle Int. 2020 Jun;41(6):714-720. doi: 10.1177/1071100720907379. Epub 2020 Mar 1.
PubMed 32116012Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a.
PubMed 15805957Davey MS, Davey MG, Hurley ET, Kearns SR. Tourniquet Use During Open Reduction and Internal Fixation of Ankle Fractures - A Systematic Review and Meta-Analysis. J Foot Ankle Surg. 2022 Sep-Oct;61(5):1103-1108. doi: 10.1053/j.jfas.2022.01.019. Epub 2022 Jan 23.
PubMed 35219596Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12.
PubMed 25979462Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305.
PubMed 15766423
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tourniquet Utilization Negatively Impact Patient Pain and Outcomes Following Operative Fixation of Rotational Ankle Fractures? A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06863688
- Acronym / sponsor ID
- 202311372
- Conditions
- Ankle Fracture
- Keywords
- Ankle Fracture, Tourniquet, PROM, Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alex DemersUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 7 Mar 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.
Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. Patients will be randomized by an Excel random number generator to a tourniquet and non-tourniquet group. Patients will remain blinded to randomization. The treating orthopaedic trauma surgeon will be notified by the PI of the study informing them of the randomization status to ensure appropriate tourniquet utilization the day of surgery. Patients will then undergo standard operative fixation and postoperative management as clinically indicated by the orthopaedic trauma team. Patients will follow-up at 2 weeks and subsequently every 4 weeks as is protocol at our institution. Patient charts will be reviewed for patient and perioperative factors, as well as postoperative complications (i.e. wound complications, need for repeat surgical intervention, and deep vein thrombosis).
Detailed description
Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. II.
Tourniquet utilization in the operative fixation of ankle fractures remains controversial and is often subject to surgeon preferences. Despite postulated benefits of minimizing blood loss, decreasing operative times, and improving visualization, tourniquets in ankle fracture fixation have been associated with increased postoperative pain, swelling, decreased range of motion, and increased opioid consumption. Previous literature has demonstrated a nonsignificant increase in wound infections and deep vein thrombosis (DVT) with tourniquet usage. Changes in perfusion intraoperatively and effects of ischemic reperfusion injury have been theorized as drivers of these negative side effects of tourniquets. Perfusion following ankle fracture fixation, thus represents an opportunity to better understand the physiologic implications of tourniquet utilization.
Tourniquet use is associated with negative outcomes after total knee arthroplasty (TKA). Despite decreased blood loss, tourniquet use in TKA has been associated with higher VAS pain scores, decreased knee range of motion and functional scores in the early postoperative period, higher rates of thrombotic events, infection, and reoperation. Impaired prosthesis survival, knee function, blood transfusion rates, quality of life, and patient satisfaction bring into question the utility of tourniquet use in TKA. These outcomes have not been thoroughly investigated in the fixation of ankle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients undergoing operative fixation of ankle fractures will be randomized to the tourniquet and no tourniquet groups in a 1:1 fashion. The treating orthopaedic trauma surgeon will be informed of the randomization status the day of surgery by the PI to ensure appropriate tourniquet utilization is executed during surgery.
| Arm | Type | Receives |
|---|---|---|
| Tourniquet Group | Experimental | Device: TourniquetPatients randomized to this group will have a tourniquet used during the operative fixation of their ankle fracture. Tourniquets will be inflated to 250 mmHg as is standard for our institution. Tourniquet will be deflated at time of closure. |
| No Tourniquet Group | Other | Other: No TourniquetPatients randomized to this group will not have a tourniquet used during operative fixation of their ankle fracture. A tourniquet will be placed on the patient's operative extremity as a safety precaution, but will remain deflated for the duration of the procedure unless emergently needed for hemostasis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 y.o. undergoing ankle fracture open reduction internal fixation
- Ground level fall as mechanism of injury
- Closed injury
Key exclusion criteria (4 listed)
- Open Ankle Fractures
- Vascular Injury Requiring Intervention
- Lower extremity injuries on same side of ankle fracture
- Active anticoagulation/bleeding disorder necessitating tourniquet use (Hemoglobin <7, PT >13, PTT>35) f) Ipsilateral lower extremity trauma impacting immobilization g) Patients with peripheral neuropathy h) Patients undergoing ankle arthroscopy
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 |
|---|---|---|
| TourniquetTourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures. | Device | Tourniquet Group |
| No TourniquetNo tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures. | Other | No Tourniquet Group |
Primary outcome
Visual Analog Scale Pain Levels
Time frame: Post anesthesia recovery unit, 2 weeks postoperatively, 6 weeks, 3 month follow-up
VAS pain scores (0-10) will be assessed for the ankle immediately postoperatively in the post anesthesia care unit and at 2 weeks, 6 weeks and 3 months postoperatively.
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores
Time frame: 6 weeks, 3 months
Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V1.1 Pain Interference (10-90, lower is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V2.0 Physical Function Score
Time frame: 6 weeks, 3 month
Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V2.0 Physical Function (10-90, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.
Patient-Reported Outcome Measurement Information System (PROMIS) Scale V1.2 Global Health Score
Time frame: 6 weeks, 3 months
Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Scale V1.2 Global Health (15-70, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.
Optimal Screening for Prediction of Referral and Outcome (OSPRO) Yellow Flag 17-Item
Time frame: 6 weeks, 3 months
OSPRO-Yf 17 questionnaires will be completed at follow-up appointments as part of standard trauma clinic workflow and will be assessed at 6 weeks, and 3 months.
1 secondary outcome
Postoperative Complications
Time frame: 6 months
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 17 Feb 2026.
- Background: PubMed 24602486Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13.
- Background: PubMed 32116012Benedick A, Rivera T, Vallier HA. Effect of Tourniquet Use During Ankle Fracture Fixation on Wound Healing and Infectious Complications. Foot Ankle Int. 2020 Jun;41(6):714-720. doi: 10.1177/1071100720907379. Epub 2020 Mar 1.
- Background: PubMed 15805957Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a.
- Background: PubMed 35219596Davey MS, Davey MG, Hurley ET, Kearns SR. Tourniquet Use During Open Reduction and Internal Fixation of Ankle Fractures - A Systematic Review and Meta-Analysis. J Foot Ankle Surg. 2022 Sep-Oct;61(5):1103-1108. doi: 10.1053/j.jfas.2022.01.019. Epub 2022 Jan 23.
- Background: PubMed 25979462Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12.
- Background: PubMed 15766423Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305.
- Individual participant dataSharing planned: No. IPD will not be shared secondary to data sharing regulations at our institution.
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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.
Alex Demers, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet and No Tourniquet in people with Ankle Fracture, run by Alex Demers 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Pain Levels (time frame: Post anesthesia recovery unit, 2 weeks postoperatively, 6 weeks, 3 month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863688, which also lists 6 linked publications.
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 17 Feb 2026.