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

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.

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

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Other: EpiFix; Other: Compression Therapy

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33433
      • Eric J. Lullove DPM
  • Massachusetts
    • Framingham, Massachusetts, United States
      • MetroWest Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • St. Johns Wound Center
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16502
      • St. Vincent's Health Center
    • Kittanning, Pennsylvania, United States, 16201
      • Armstrong County Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1 application of EpiFix; 1 x dehydrated human amnion/chorion membrane	Other: EpiFix; Dehydrated placental tissue; Other: Compression Therapy; Compression bandaging
Other: 2 applications of EpiFix; 2 x dehydrated human amnion/chorion membrane	Other: EpiFix; Dehydrated placental tissue; Other: Compression Therapy; Compression bandaging
Other: Standard of care; Compression bandaging	Other: Compression Therapy; Compression bandaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of wounds achieving 40% closure in patients treated with amniotic membrane vs. standard of care	4 week

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. standard of care	4 week
The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. 2 applications of amniotic membrane	4 week
The proportion of wounds achieving 40% closure in patients treated with two applications of amniotic membrane vs. standard of care	4 week

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Thomas E Serena, MD, Penn North Centers for Advanced Wound Care

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: EFVLU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided