Comparative Study of Two Application Regimens 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: NCT01657474
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
MiMedx Group, Inc.

Brief Summary:
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: Weekly application of EpiFix plus standard of care Other: Biweekly application of EpiFix plus standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Comparative Study of Amniotic Membrane Wound Graft With Weekly Versus BiWeekly Application In the Management of Diabetic Foot Ulcers
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Weekly Application of EpiFix
Weekly application of EpiFix plus standard of care
Other: Weekly application of EpiFix plus standard of care
Experimental: Biweekly application of EpiFix
Biweekly application of EpiFix plus standard of care
Other: Biweekly application of EpiFix plus standard of care

Primary Outcome Measures :
  1. Mean time to healing [ Time Frame: up to 12 Week ]

Secondary Outcome Measures :
  1. Proportion of completely healed ulcers [ Time Frame: Week 4 and Week 12 ]
  2. Percent change in wound area [ Time Frame: Week 4 and Week 12 ]

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
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female age 18 or older
  2. Informed consent must be obtained
  3. 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.
  4. Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
  5. Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two week run in period will precede enrollment/randomization in the trial to document the indolent nature of the wounds selected
  6. Additional wounds may be present but not within 3cm of the study wound
  7. Wound must be present anatomically on the plantar surface of the foot
  8. Patient's ulcer must exhibit no clinical signs of infection.
  9. Patient is of legal consenting age.
  10. Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
  11. Serum Creatine less then 3.0mg/dl
  12. HbA1c less than 12%
  13. 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:

  1. 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.
  2. Patients whose index diabetic foot ulcers are greater than 25cm2.
  3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days,
  4. Patients whose serum creatinine levels are 3.0mg/dl or greater.
  5. Patients with a known history of poor compliance with medical treatments.
  6. Patients who have been previously randomized into this study, or are presently participating in another clinical trial
  7. Patients who are currently receiving radiation therapy or chemotherapy.
  8. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
  9. Patients diagnosed with autoimmune connective tissues diseases.
  10. Non-revascularizable surgical sites
  11. Active infection at site
  12. Any pathology that would limit the blood supply and compromise healing;
  13. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days
  14. Patient who are pregnant or breast feeding
  15. Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.
  16. Allergy to Gentamycin or Streptomycin
  17. Wounds greater than one year in duration without intermittent healing
  18. Wound improving greater than 20% over the first two weeks of the trial using standard of care dressing and Cam Boot

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): NCT01657474

United States, Virginia
Professional Education and Research Institute
Roanoke, Virginia, United States, 24016
Professional Education and Research Institute
Salem, Virginia, United States, 24153
Sponsors and Collaborators
MiMedx Group, Inc.
Principal Investigator: Charles M. Zelen, DPM Professional Education and Research Institute

Responsible Party: MiMedx Group, Inc. Identifier: NCT01657474     History of Changes
Other Study ID Numbers: EFDFU002
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

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