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

NCT02609594 | Unknown

• 1 other identifier: AMNIOVLU01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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.

Conditions

Venous Leg Ulcers

Keywords

human amniotic membrane; compression therapy; venous leg ulcer

Outcome Measures

Primary Outcomes (1)

• Time to complete ulcer closure

  Ulcer closure is based on wound area measurement and absence of wound exudate.

  12 weeks

Secondary Outcomes (5)

• Proportion of ulcers achieving 40% ulcer closure

  4 weeks

• Percentage of ulcers achieving complete closure

  12 weeks

• Incidence of adverse events

  12 weeks

• Cost effectiveness

  12 weeks

• Reduction in pain between treatment groups

  12 weeks

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Subjects randomized to this group will receive standard of care (multi-layer compression therapy).

Other: Standard of Care

Weekly application of Amnioband

EXPERIMENTAL

Weekly application of Amnioband plus standard of care.

Other: Weekly application of Amnioband; Other: Standard of Care

Biweekly application of Amnioband

EXPERIMENTAL

Biweekly application of Amnioband plus standard of care.

Other: Biweekly application of Amnioband; Other: Standard of Care

Interventions

Weekly application of Amnioband OTHER

Weekly application of Amnioband.

Weekly application of Amnioband

Biweekly application of Amnioband OTHER

Biweekly application (every two weeks) of Amnioband.

Biweekly application of Amnioband

Standard of Care OTHER

Standard of care for this study is weekly multi-layer compression bandaging.

Biweekly application of Amnioband; Standard of Care; Weekly application of Amnioband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Ankle Brachial Pressure Index (ABI) \> 0.75 OR SPP \> 30 mmHg OR TCOM \> 30 mmHg.\*
• Presence of a 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 leg they have to be more than 2 cm apart from the index ulcer.
• Study ulcer (i.e. current episode of ulceration) has been present for greater than one month prior to the initial screening visit, and has failed to respond to documented conservative measures for greater than (1) one month duration 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).
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

You may not qualify if:

• 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.
• Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
• 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.
• Subjects 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 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.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
• Study ulcer improving greater than 30% during the screening phase if the subject was not in adequate compression 14 days prior to screening.
• History of drug or alcohol abuse.
• History of radiation at the ulcer site.
• Presence of one or more medical conditions, as determined by medical history, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this ulcer healing study.
• 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.
• 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.
• Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (8)

Brigham and Women's Hospital Wound Care Center

Boston, Massachusetts, 02115, United States

RECRUITING

Premier Surgical

Brick, New Jersey, 08723, United States

RECRUITING

Inspira Medical Center - Elmer Wound Care Center

Elmer, New Jersey, 08318, United States

COMPLETED

St John Medical Center

Tulsa, Oklahoma, 74135, United States

COMPLETED

The Foot and Ankle Wellness Center

Ford City, Pennsylvania, 16226, United States

RECRUITING

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

RECRUITING

SerenaGroup Research Institute

Pittsburgh, Pennsylvania, 15222, United States

RECRUITING

Martinsville Research Institute

Martinsville, Virginia, 24112, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Linda Squillante

  Musculoskeletal Transplant Foundation

  STUDY DIRECTOR

Central Study Contacts

Heather Connell, CCRP

CONTACT

617-383-3979

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (8)