Trial of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

This study is currently recruiting participants.
Verified December 2012 by MiMedx Group, Inc.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01693133
First received: September 19, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Diabetic Foot Ulcer
Other: Standard of Care: Moist Wound Therapy
Other: EpiFix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized, Controlled, Comparative Parallel Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • The proportion of ulcers achieving 50% wound area reduction in the EpiFix group versus the Control group [ Time Frame: 4 Week ]

Secondary Outcome Measures:
  • Time to complete closure for both groups [ Time Frame: Up to 6 Weeks ]

Estimated Enrollment: 120
Arms Assigned Interventions
Control
Standard of Care: Moist Wound Therapy
Other: Standard of Care: Moist Wound Therapy
Standard of Care: Moist Wound Therapy
Experimental: EpiFix
Weekly application of EpiFix and standard of care
Other: EpiFix
Weekly application of EpiFix and Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 18 or older
  • Informed consent must be obtained
  • Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2.

Debridement will be done prior to randomization.

  • Wounds should be diabetic foot ulcers located on the plantar surface of the foot.
  • 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, with documented failure of prior treatment to heal the wound (< 20% wound area reduction for two consecutive weeks immediately prior to enrollment when treated with standard protocol of care).
  • 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 ulcer is smaller than 1 cm2 or greater than 25cm2. Or multiple wounds on the same foot where other wounds are within 5 cm of the wound under care.
  • 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 diagnosed with autoimmune connective tissues diseases.
  • Nonrevascularizable 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
  • Active Charcot deformity or major structural abnormalities of the foot.
  • Wounds that are not on the plantar surface of the foot.
  • Wounds that are greater than one year in duration without intermittent closure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693133

Contacts
Contact: Pasquale Cancelliere, DPM (508) 872-9288 Pasquale.Cancelliere@MWMC.com

Locations
United States, Massachusetts
MetroWest Medical Center Recruiting
Framingham, Massachusetts, United States, 01702
Principal Investigator: Pasquale Cancelliere, DPM         
Sub-Investigator: Donald Adams, DPM         
Sub-Investigator: James Parlon, DPM         
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Pasquale Cancelliere, DPM Metro West Medical Center
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01693133     History of Changes
Other Study ID Numbers: EFDFU003
Study First Received: September 19, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014