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

NCT02609594 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-09-07

No results posted yet for this study

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

Interventions

OTHER

Weekly application of Amnioband

Weekly application of Amnioband.

OTHER

Biweekly application of Amnioband

Biweekly application (every two weeks) of Amnioband.

OTHER

Standard of Care

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

Sponsors & Collaborators

  • Musculoskeletal Transplant Foundation

    collaborator OTHER

  • SerenaGroup, Inc.

    lead NETWORK

Principal Investigators

  • Linda Squillante · Musculoskeletal Transplant Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609594 on ClinicalTrials.gov