A Multicenter Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in The Management of Diabetic Foot Ulcers

  • STATUS
    Recruiting
  • sponsor
    MiMedx
Updated on 23 November 2020

Summary

A Multicenter Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in The Management of Diabetic Foot Ulcers

Description

The purpose of this clinical study is to see how safe and well EpiCord Dehydrated Human Umbilical Cord Allograft plus moist wound therapy and offloading, meaning reduced-weight bearing (Standard of Care) works versus Standard of Care alone in the treatment of diabetic foot ulcers.

The purpose of this clinical study is to see if DFUs heal faster and stay healed longer when EpiCord is used along with the standard of care (SOC) therapy, or if patients do equally well with standard of care (SOC) alone.

  • Subjects who qualify will receive study-related treatment at no cost.
  • Reimbursement for time and travel will be provided.

Details
Condition Diabetic Foot Ulcers
Clinical Study IdentifierTX146105
SponsorMiMedx
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a Diabetic Foot Ulcer beneath your ankle
Have a Diabetic Foot Ulcer which is bigger than your thumb nail but smaller than the palm of your hand
Be prepared to wear compression bandages
Be available for weekly follow-up assessments for 12 weeks
Clear my responses

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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