Pickerington, OHNCT07510412Now EnrollingIRB Ready

Venous Leg Ulcers Clinical Trial in Pickerington, OH

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

Sponsored by Organogenesis

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Expert Care in Pickerington

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 Pickerington, OH

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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 Pickerington

    Convenient for OH 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 Pickerington site if eligible
  4. 4Begin participation

About This Venous Leg Ulcers Study in Pickerington

A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.

Sponsor: Organogenesis

Who Can Participate

Inclusion Criteria

Subjects must be at least 18 years of age or older.
Index Ulcer must be of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test)
The index ulcer must have been present for a minimum of 4 weeks
The subject must have a study wound that falls within a specified size range
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 index ulcer.
Index ulcer is located on the leg, below the knee and at or above the malleoli.
Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.
Subjects agree to be compliant with all study requirements, including weekly study visits.
Females of childbearing potential must use acceptable methods of contraception (birth control pills, barriers, or abstinence) for at least one month prior to randomization and for the duration of study participation. Males must be willing to use acceptable methods of birth control (barriers or abstinence) from randomization through study participation.
Adequate circulation to the affected limb as documented by any of the following methods performed within 3 months prior to the first screening visit:
TCOM \> 30 mmHg
ABI \> 0.75
SPP \> 30mmHg
As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.
Subject failed to adequately respond to conventional therapy Exclusion Criteria:
Index ulcer is of non-venous pathophysiology.
Subjects unable to tolerate sharp debridement and standard compression therapy.
If, at the opinion of the investigator, the index wound requires debridement necessitating surgery or enzymatic therapies.
The surface area measurement of the index ulcer has reduced in size by a specified amount from the initial screening visit (SV1) to Visit 1/randomization visit
Subjects receiving systemic steroids greater than 5 mg of Cortisone per day or equivalent.
A subject who, in the opinion of the Investigator, has a clinically relevant medical condition which could impact subject safety, impair treatment effectiveness, or otherwise interfere with their ability to comply with study requirements.
Signs and symptoms of index ulcer infection, including but not limited to cellulitis or osteomyelitis (as evidenced by Investigator's exam or x-ray).
Necrotic or avascular index ulcer beds.
Index ulcer contains exposed muscle, tendon, bone, or joint capsule.
Subjects receiving hemodialysis or having a creatinine level of \> 3.0mg/dL within 6 months of randomization.
Subjects with an HbA1c level of \>12% within 3 months of randomization (if the subject is diabetic).
Topical application of steroids to the index ulcer surface within one month of initial screening.
Subjects who are currently receiving, or who previously received at any time within one month prior to screening, immunosuppressive agents (including inhaled corticosteroids and oral cortisone 5 mg or more daily), radiation therapy, or chemotherapy. Anticipated use of any of the above agents is considered exclusionary.
Subjects who are pregnant or breast-feeding.
Subjects with a history of poor compliance with medical treatment or who are unwilling or unable to adhere to the protocol requirements.

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 Pickerington?

Yes, this clinical trial (NCT07510412) has an active research site in Pickerington, OH 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 Pickerington, OH

If you're searching for venous leg ulcers treatment options in Pickerington, OH, this clinical trial (NCT07510412) 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 Pickerington 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 · Pickerington, OH