A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

MiMedx Group, Inc.1 site in 1 country25 target enrollmentMarch 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: MiMedx Group, Inc.
Enrollment: 25
Locations: 1
Primary Endpoint: The proportion of completely healed ulcers in patients treated with amniotic membrane vs. standard of care
Status: Completed
Last Updated: 10 years ago

The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

August 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Male or female age 18 or older
•Informed consent must be obtained
•Patient's ulcer must be diabetic in origin and larger than 1cm
•Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
•Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
•Ulcer must be present for a minimum of four weeks direction, with documented failure of prior treatment to heal the wound.
•Patient's ulcer must exhibit no clinical signs of infection.
•Patient is of legal consenting age.
•Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
•Serum Creatine less then 3.0mg/dl

•Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
•Patients whose index diabetic foot ulcers are greater than 25cm
•Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days,
•Patients whose serum creatinine levels are 3.0mg/dl or greater.
•Patients with a known history of poor compliance with medical treatments.
•Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
•Patients who are currently receiving radiation therapy or chemotherapy.
•Patients with known or suspected local skin malignancy to the index diabetic ulcer.
•Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
•Patients diagnosed with autoimmune connective tissues diseases.