Clinical Trial Details

Overview

Research Study Summary

Clinical trial to evaluate the efficacy and safety of investigational product in treating non-healing foot ulcers in subjects with diabetes mellitus

Purpose

Clinical trial to evaluate the efficacy and safety of investigational product in treating non-healing foot ulcers in subjects with diabetes mellitus

To Learn more

CW ID: 198642
Date Last Changed: September 4, 2014

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Duration
24 Weeks
Facility Type
N/A
Compensation
Up to $1,500

Eligibility

Inclusion Criteria:

  • Patients diagnosed with Type I or Type 2 Diabetes with at least one chronic (present for at least one month and no more than 10 months), non-healing plantar neuropathic foot ulcer of 0.75 - 6.0cm on the midfoot or forefoot.
  • Male or female 18 years or older
  • Diabetes T1 or T2 with HbA1c of <12% and a serum creatinine level of <3mg/dl
  • Comply with study procedures
  • At screening, at least one chronic non-healing target ulcer
  • Non healing as defined as <30% reduction in size in response to standard of care during the screening period
  • Partial-or-full skin thickness not involving bone, tendon, or capsule
  • No sign of infection or osteomyelitis
  • Whole ulcer predominantly on the plantar surface of the foot

More Info

Length of Subject enrollment: total of 24 weeks
$75 per visit for time and travel. May be compensated up to $1,500

Contact

Maria Elena Paredes, Study Coordinator
Miami Dade Medical Research Institute, LLC
8955 SW 87TH Court Suite 112
Miami, FL 33176
Phone: 305-722-7210

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Research Center Information:

Miami Dade Medical Research Institute, LLC

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

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