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Diabetic Foot Ulcer - Healing Genes
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Diabetic Foot Ulcer

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DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers


Phase Not Applicable

DESCRIPTION:

Researchers in Fresno, CA, and Rocky Mount, NC, are recruiting patients with chronic grade 3 or 4 diabetic foot ulcers or other deep soft tissue defects in their lower extremities to trial a new allogeneic (donor) acellular wound matrix called Dermacell AWM. This engineered tissue graft is created from the collagen-rich matrix layer of the dermis and contains no cells, but can be grown into by the patient’s own body and become healthy skin.

The treatment will require surgical placement of the graft and patients will then be followed in the outpatient clinic for up to 16 weeks.


PATIENT MUST:

  • Be 21 to 85 years of age
  • Have a target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
  • Not be pregnant

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Wound bed will be prepared for the graft.
  3. Surgical placement of the graft, then follow-up in the outpatient clinic for up to 16 weeks.

LOCATIONS AND CONTACTS:

Trials will take place at the Limb Preservation Platform in Fresno, CA. Map.

Purvis Moyer Foot and Ankle Center in Rocky Mount, NC. Map.

 

Contact: Kimberly Dorsch  |  757-609-4378  |  [email protected]

 

SPONSOR INFORMATION:

LifeNet Health

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03044132

 

 

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