Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle… (NCT05092646) | Clinical Trial Compass
TerminatedPhase 1/2
Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis
Stopped: This study was terminated by the Sponsor in December 2023 due to business considerations.
United States12 participantsStarted 2021-12-01
Plain-language summary
A Double-blind, Multi-Center, Prospective, Randomized Placebo-controlled Pilot Study Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects with Ankle Osteoarthritis. The goal of this pilot study and subsequent pivotal trial is to evaluate the safety and effectiveness of Axolotl Ambient intra-articular injection for ameliorating the pain and dysfunction associated with ankle OA.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed written informed consent
. Willing to be randomized to either the investigational or control group
. Male or female at least 18 years of age and less than 80
. Clinical diagnosis of symptomatic tibiotalar (ankle) OA (primary idiopathic OA or post-traumatic OA), modified K-L grade 1-3a
. One ankle is the most symptomatic lower extremity joint and the only lower extremity joint currently planned for treatment
. Willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations
. For women of childbearing potential (not post-menopausal for 12 months or surgically sterile), a urine pregnancy test with a negative result must be obtained at screening and on the day of procedure, prior to injection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale
Timeframe: 4-weeks, 3-months, and 6-months
2
Change From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale
Timeframe: 4-week, 3 Months, 6-months
3
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale
Timeframe: 4-weeks, 3-months, 6-months
4
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale
Timeframe: 4-weeks, 3-months, 6-months
5
Proportion of Patients Achieving Composite Clinical Success (CCS).
. Male and female trial participants must commit to adequate birth control (e.g., surgically sterilized, oral contraceptive, two methods of barrier birth control, or abstinence) through the final follow-up
Exclusion criteria
. Previously received intra-articular injections in the index joint of Axolotl Ambient, bone marrow aspirate concentrate (BMAC), platelet-rich plasma (PRP), or other biologic-based products within the last 12 months.
. Modified K-L Grade 3b or 4 osteoarthritis of the index joint
. Diagnosis of ipsilateral peri-articular arthritis (e.g. subtalar joint) that the investigator determines may significantly confound the study results
. Received intra-articular hyaluronic acid injection in the index joint within the last 6 months
. Received intra-articular steroid injection in the index joint within the last 3 months
. Prior major surgical repair or reconstruction of the ankle that the investigator determines may significantly confound the study results
. Baseline pain catastrophizing score ≥ 23
. Any surgery of the index ankle within the last 12 months