Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Skye Biologics Holdings, LLC
Study ID
NCT06764953
Status
Recruiting
Apply to this trial

Conditions

  • Venous Leg Ulcers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E-GRAFT ™ — OTHER
    E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act.
  • FIBRACOL™ — DEVICE
    510K FDA cleared Collagen alginate dressing

Study Details

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Change in pain levels * Occurrence of infection

Key Dates

Start date
Dec 28, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SOC primary dressing with E-GRAFT ™
    Participants receive standard of care with E-GRAFT™
  • Active Comparator: SOC primary dressing with FIBRACOL™
    Participants receive standard of care with FIBRACOL™

Primary Outcome Measure

Comparison of the proportion of index ulcers "healed" at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Professional Education and Research InstituteRoanokeVirginia24016
Charles M Zelen, DPM FACFAS

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Professional Education and Research Institute· Roanoke, VA

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