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Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

NCT03424746 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-06-10

No results posted yet for this study

Summary

This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease

Interventions

DRUG

disodium EDTA

Open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year.

Sponsors & Collaborators

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Gervasio Lamas, MD · Mount Sinai Medical Center of Florida

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-01-31
Completion
2019-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03424746 on ClinicalTrials.gov