Use of dHACM in the Treatment of Venous Leg Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by MiMedx Group, Inc.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT02011503
First received: November 21, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to healing in patients with venous leg ulcers (VLUs).


Condition Intervention
Leg Ulcer
Procedure: Multi-layer compression therapy
Other: Application of dHACM

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 Randomized Controlled Clinical Trial Evaluating The Application Of Dehydrated Human Amnion/ Chorion Membrane (dHACM) Plus Standard Of Care Vs. 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:
  • Reduction in wound size by ≥40% between both groups [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients in both groups with complete wound healing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Comparison of Quality of Life as assessed by Short Form 36 (SF-36) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dHACM
Application of multi-layer compression therapy with application of dHACM.
Procedure: Multi-layer compression therapy
Application of multi-layer compression therapy.
Other: Application of dHACM
Application of dHACM to ulcer.
Control
Application of multi-layer compression therapy without application of dHACM.
Procedure: Multi-layer compression therapy
Application of multi-layer compression therapy.

  Eligibility

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

Inclusion Criteria:

  1. Are at least 18 years old.
  2. Have Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms).
  3. Have venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone. The largest ulcer will be designated the index ulcer and the only one included in the study. If other ulcerations are present on the same extremity, these must be more than 2 cm apart from the index ulcer.
  4. Have venous insufficiency confirmed by duplex ultrasound examination for valvular or venous incompetence.
  5. Have study ulcer (i.e. current episode of ulceration) that has been present for at least one month prior to the initial screening visit. Note: The patient is excluded if ulcer has undergone 12 months of continuous high strength compression therapy over its duration.
  6. Have study ulcer with a minimum of 2 cm2 and a maximum of 25 cm2 at the randomization visit.
  7. The target ulcer has been treated with compression therapy for at least 14 days prior to randomization.
  8. Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
  9. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  10. Patient understands and is willing to comply with weekly visits and the follow-up regimen.
  11. Patient has read and signed the Institutional Review Board (IRB) approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

  1. Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
  2. Study ulcer exhibits clinical signs and symptoms of infection.
  3. Study ulcer, in the opinion of the investigator, is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma.
  4. Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days of 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.
  5. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
  6. History of radiation at the ulcer site.
  7. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  8. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Meristem) within the last 30 days
  9. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
  10. Patients who are unable to understand the aims and objectives of the trial.
  11. 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.
  12. New York Heard Association (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.
  13. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
  14. Pregnant or breast feeding.
  15. Currently taking medications which, in the opinion of the treating physician, could affect graft incorporation.
  16. Allergic to gentamicin and/or streptomycin
  17. Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
  18. History of drug or alcohol abuse within 6 months of screening.
  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: NCT02011503

Contacts
Contact: Richard Odom, DPM Richard.Odom@va.gov

Locations
United States, Georgia
Atlanta Veteran's Administration Recruiting
Decatur, Georgia, United States, 30033
Principal Investigator: Richard Odom, DPM         
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Richard Odom, DPM Veteran's Administration
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02011503     History of Changes
Other Study ID Numbers: EFVLU003
Study First Received: November 21, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014