Roanoke, VANCT06764953Now EnrollingIRB Ready

Venous Leg Ulcers Clinical Trial in Roanoke, VA

Access cutting-edge venous leg ulcers treatment through this clinical trial at a research site in Roanoke. Study-provided care at no cost to qualified participants.

Sponsored by Skye Biologics Holdings, LLC

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Expert Care in Roanoke

Access venous leg ulcers specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related venous leg ulcers treatment provided free

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Check if you qualify for this venous leg ulcers clinical trial in Roanoke, VA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Roanoke

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Roanoke site if eligible
  4. 4Begin participation

About This Venous Leg Ulcers Study in Roanoke

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

Sponsor: Skye Biologics Holdings, LLC

Who Can Participate

Inclusion Criteria

Subjects must be at least 18 years of age or older.
At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and

Exclusion Criteria

will be designated as the target ulcer.
The subject must consent to using the prescribed off-loading method for the duration of the study.
The subject must agree to attend the weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process.
The target ulcer must be full thickness on the foot or leg that does not probe to bone.
Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
TCOM ≥30 mmHg
ABI between 0.7 and 1.3
PVR: Biphasic
As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
Target ulcers must have been treated with compression therapy for at least 14 days prior to randomization. Exclusion Criteria:
A subject known to have a life expectancy of \< 6 months is excluded.
If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
A subject with a previous partial amputation on the affected leg is excluded if the resulting deformity impedes proper offloading of the target ulcer.
If a subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
A potential subject with end stage renal disease requiring dialysis is excluded.
A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Roanoke?

Yes, this clinical trial (NCT06764953) has an active research site in Roanoke, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Venous Leg Ulcers Treatment Options in Roanoke, VA

If you're searching for venous leg ulcers treatment options in Roanoke, VA, this clinical trial (NCT06764953) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Roanoke research site is actively enrolling participants for this clinical trial. You'll receive care from experienced venous leg ulcers specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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Secure · Expert Care · Roanoke, VA