Amnioband and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
Public ClinicalTrials.gov record NCT02609594. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 of Venous Leg Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02609594
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Interventions
- Weekly application of Amnioband Other
- Biweekly application of Amnioband Other
- Standard of Care Other
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2015
- Primary completion
- Nov 30, 2018
- Completion
- Nov 30, 2018
- Last update posted
- Sep 6, 2018
2015 – 2018
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brigham and Women's Hospital Wound Care Center | Boston | Massachusetts | 02115 | Recruiting |
| Premier Surgical | Brick | New Jersey | 08723 | Recruiting |
| Inspira Medical Center - Elmer Wound Care Center | Elmer | New Jersey | 08318 | Completed |
| St John Medical Center | Tulsa | Oklahoma | 74135 | Completed |
| The Foot and Ankle Wellness Center | Ford City | Pennsylvania | 16226 | Recruiting |
| Armstrong County Memorial Hospital | Kittanning | Pennsylvania | 16201 | Recruiting |
| SerenaGroup Research Institute | Pittsburgh | Pennsylvania | 15222 | Recruiting |
| Martinsville Research Institute | Martinsville | Virginia | 24112 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02609594, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 6, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02609594 live on ClinicalTrials.gov.