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

Venous Leg Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552447
• Other study ID #: EFVLU001
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: March 14, 2016
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: March 2016
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Other:
• EpiFix
Dehydrated placental tissue
• Compression Therapy
Compression bandaging

Locations

Country	Name	City	State
United States	Eric J. Lullove DPM	Boca Raton	Florida
United States	St. Vincent's Health Center	Erie	Pennsylvania
United States	MetroWest Medical Center	Framingham	Massachusetts
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	St. Johns Wound Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of wounds achieving 40% closure in patients treated with amniotic membrane vs. standard of care		4 week	No
Secondary	The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. standard of care		4 week	No
Secondary	The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. 2 applications of amniotic membrane		4 week	No
Secondary	The proportion of wounds achieving 40% closure in patients treated with two applications of amniotic membrane vs. standard of care		4 week	No