Your session is about to expire
← Back to Search
Chelating Agent
Chelation Therapy for Critical Limb Ischemia (TACT3a Trial)
Phase 3
Recruiting
Led By Gervasio Lamas, MD
Research Sponsored by Mt. Sinai Medical Center, Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 50 years
Significant stenosis (≥ 75%) of two or more infra-popliteal arteries in the affected limb as verified by at least one imaging technique (angiography, magnetic resonance angiogram, coronary computed tomography angiogram, or doppler examination) within 6 months prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years (average follow-up 1.25 years)
Awards & highlights
TACT3a Trial Summary
This trial is testing a new therapy to see if it can reduce the risk of cardiovascular events and amputations in high-risk diabetic patients.
Who is the study for?
This trial is for diabetic patients over 50 with critical limb ischemia, who have severe artery blockages in their legs and are not candidates for surgery. They must have had pain or non-healing wounds due to poor blood flow for at least two weeks. Smokers or those with recent heart failure, severe kidney disease, certain metabolic disorders, active infections, or a history of chelation therapy are excluded.Check my eligibility
What is being tested?
The TACT3a study is testing whether edetate disodium can reduce cardiovascular events including amputation in high-risk diabetic patients with critical limb ischemia. Participants will be randomly assigned to receive either the actual drug or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
While specific side effects of edetate disodium aren't listed here, chelation therapy can sometimes cause headaches, nausea, dizziness, low calcium levels in the blood and may lead to kidney damage if not monitored carefully.
TACT3a Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I have severe narrowing in two or more arteries below my knee confirmed by a scan within the last 6 months.
Select...
I have diabetes, as shown by my use of insulin or oral medications, or my blood sugar or HbA1c levels.
Select...
I have severe leg pain or non-healing wounds due to poor blood flow.
Select...
I cannot undergo or have unsuccessfully undergone heart vessel repair surgery.
TACT3a Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years (average follow-up 1.25 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years (average follow-up 1.25 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiovascular system
Secondary outcome measures
Amputations
Changes in PAD Quality of Life
Changes in Pain severity
+6 moreTACT3a Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
edetate disodium (EDTA)dff active infusion
Group II: PlaceboPlacebo Group1 Intervention
Placebo infusion
Find a Location
Who is running the clinical trial?
Mt. Sinai Medical Center, MiamiLead Sponsor
18 Previous Clinical Trials
4,040 Total Patients Enrolled
Gervasio Lamas, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Electrophysiology Consultants of Florida, Le Heart Center Llc, Mount Sinai Medical Center
New York University School Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)
3 Previous Clinical Trials
241 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery to improve blood flow in my legs, neck, or heart less than a week ago.I have severe pain that can't be controlled with medication.I am a woman who can become pregnant.I have poor blood flow in my legs not due to clogged arteries.My liver enzymes are higher than normal.I have severe tissue death extending above my mid-toe joint.I was hospitalized for heart failure in the last 3 months.I have a condition related to copper, iron, or calcium metabolism, excluding osteopenia, osteoporosis, or simple iron deficiency.I am 50 years old or older.I have severe narrowing in two or more arteries below my knee confirmed by a scan within the last 6 months.My kidney function is reduced, with an eGFR below 30 mL/min.I haven't had more than one chelation therapy in the past 5 years.I have diabetes, as shown by my use of insulin or oral medications, or my blood sugar or HbA1c levels.You can't handle the amount of fluids needed for the study.I have severe leg pain or non-healing wounds due to poor blood flow.I have an active infection or a deep wound exposing bone or tendon.I have taken FDA-approved medication to remove excess metals from my body in the last 2 years.You have smoked cigarettes in the past 3 months.I am scheduled for a procedure to improve blood flow in my legs within a month.I am experiencing symptoms of heart failure.Your platelet count is less than 100,000 per cubic millimeter.You do not have a way for the study drug to be given through your veins.I do not have any health conditions that could shorten my life within the next 3 years.I cannot undergo or have unsuccessfully undergone heart vessel repair surgery.Your blood pressure is higher than 160 over 100.You have a known or suspected sudden kidney problem based on specific medical criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some risks associated with taking Active?
"There is evidence from Phase 3 trials to suggest that Active is safe, so it received a score of 3."
Answered by AI
How many participants will this trial have in total?
"The information available on clinicaltrials.gov indicates that this study is currently recruiting patients. This particular trial was posted on March 19th, 2019 and was updated as recently as March 4th, 2022. A maximum of 50 patients will be enrolled at 1 location."
Answered by AI
Are there any other ongoing research projects that use Active as a treatment?
"Currently, there is 1 study underway for the Active treatment. Out of the 1 live trials, 1 is in Phase 3. The majority of research for Active is based in Miami Beach, Florida; however, there is 1 other location running clinical trials."
Answered by AI
Are we still able to sign up for this clinical trial?
"That is correct. The clinical trial, which was originally posted on March 19th, 2019, is still recruiting patients. The trial is admitting 50 patients from 1 location."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger