Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552499
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 17, 2015
Information provided by (Responsible Party):
MiMedx Group, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: Standard of care Other: Applications of EpiFix Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
Study Start Date : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Control Other: Standard of care
Experimental: Treatment Other: Standard of care Other: Applications of EpiFix

Primary Outcome Measures :
  1. The proportion of completely healed ulcers in patients treated with amniotic membrane vs. standard of care [ Time Frame: 12 week ]

Secondary Outcome Measures :
  1. Percent change in wound area [ Time Frame: 4 week ]
  2. Mean time to complete healing [ Time Frame: Up to 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Male or female age 18 or older
  • Informed consent must be obtained
  • Patient's ulcer must be diabetic in origin and larger than 1cm2. 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
  • HbA1c less than 12%
  • Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

    • Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
    • ABIs with results of ≥0.7 and ≤1.2, OR
    • Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg

Exclusion Criteria:

  • 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 25cm2.
  • 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.
  • Non-revascularizable surgical sites.
  • Active infection at site.
  • Any pathology that would limit the blood supply and compromise healing.
  • Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
  • Patient who are pregnant or breast feeding.
  • Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.
  • Allergy to Gentamycin or Streptomycin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552499

United States, Virginia
Professional Education and Research Institute
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
MiMedx Group, Inc.
Principal Investigator: Charles M. Zelen, DPM Professional Education and Research Institute

Responsible Party: MiMedx Group, Inc. Identifier: NCT01552499     History of Changes
Other Study ID Numbers: EFDFU001
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases