Clinical Trial: Amnioband and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Amnioband Dehydrated Human Amniotic Membrane and Standard of Care vs. Standard of Care Alone in the Treatment

Brief Summary:

Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.

Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.

Detailed Summary:

This study is a multi-center, randomized, trial designed to evaluate the safety and effectiveness of Amnioband Dehydrated Human Amniotic Membrane plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.

The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The choice of compression will be at the discretion of the principle investigator.

The Screening Phase (1-14 days) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), At or up to 14 days before the first Screening Period Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.

Subjects who have not been treated with compression therapy for the target ulcer must receive a minimum of 14 days of compression prior to enrollment.

At the first Screening Period Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.

The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Period of the study.

The Treatment Phase (12 Weeks) begins with a series of assessments designed
Sponsor: SerenaGroup, Inc.

Current Primary Outcome: Time to complete ulcer closure [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Proportion of ulcers achieving 40% ulcer closure [ Time Frame: 4 weeks ]
  This is measured by wound area.
• Percentage of ulcers achieving complete closure [ Time Frame: 12 weeks ]
  This is measured by wound area and absence of wound exudate.
• Incidence of adverse events [ Time Frame: 12 weeks ]
• Cost effectiveness [ Time Frame: 12 weeks ]
  The per unit cost of providing wound care is known. The use of amniotic membrane to standard of care will be compared in terms of the cost of achieving healing.
• Reduction in pain between treatment groups [ Time Frame: 12 weeks ]
  Pain is measured by subject report on a scale of 0 to 10.

Original Secondary Outcome: Same as current

Information By: SerenaGroup, Inc.

Dates:
Date Received: November 16, 2015
Date Started: November 2015
Date Completion: September 2017
Last Updated: May 16, 2017
Last Verified: May 2017