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Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01552447
First received: March 6, 2012
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.

Condition Intervention
Venous Leg Ulcer
Other: EpiFix
Other: Compression Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The proportion of wounds achieving 40% closure in patients treated with amniotic membrane vs. standard of care [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. standard of care [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  • The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. 2 applications of amniotic membrane [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  • The proportion of wounds achieving 40% closure in patients treated with two applications of amniotic membrane vs. standard of care [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 application of EpiFix
1 x dehydrated human amnion/chorion membrane
Other: EpiFix
Dehydrated placental tissue
Other: Compression Therapy
Compression bandaging
2 applications of EpiFix
2 x dehydrated human amnion/chorion membrane
Other: EpiFix
Dehydrated placental tissue
Other: Compression Therapy
Compression bandaging
Standard of care
Compression bandaging
Other: Compression Therapy
Compression bandaging

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Ankle Brachial Pressure Index (ABI) > 0.75
  • Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone
  • Study ulcer has been present for at least one month prior to the initial screening visit, and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration
  • Study ulcer is a minimum of 2 cm2 and a maximum of 20 cm2 at the Randomization visit
  • The target ulcer has been treated with compression therapy for at least 14 days prior to randomization
  • Ulcer has a clean, granulating base with minimal adherent slough at the Randomization visit
  • Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  • Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen
  • Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken

Exclusion Criteria:

  • Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency
  • Study ulcer exhibits clinical signs and symptoms of infection.
  • Non-mobile i.e. not ambulatory, or bed ridden
  • Study ulcer, in the opinion of the investigator, is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
  • Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
  • Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening
  • History of radiation at the ulcer site
  • Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  • Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days
  • Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
  • Patients who are unable to understand the aims and objectives of the trial
  • Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment
  • NYHA Class III and IV congestive heart failure (CHF), as defined by the following criteria: Class III: Symptoms with moderate exertion; Class IV: Symptoms at rest
  • Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
  • Pregnant or breast feeding
  • Currently taking medications which could affect graft incorporation.(supervising physicians discretion)
  • Allergic to gentamicin and streptomycin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552447

Locations
United States, Florida
Eric J. Lullove DPM
Boca Raton, Florida, United States, 33433
United States, Massachusetts
MetroWest Medical Center
Framingham, Massachusetts, United States
United States, Oklahoma
St. Johns Wound Center
Tulsa, Oklahoma, United States
United States, Pennsylvania
St. Vincent's Health Center
Erie, Pennsylvania, United States, 16502
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Thomas E Serena, MD Penn North Centers for Advanced Wound Care
  More Information

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01552447     History of Changes
Other Study ID Numbers: EFVLU001 
Study First Received: March 6, 2012
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016