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Compares treatment options for Venous Leg Ulcers
Official title 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)
ClinicalTrials.gov ID: NCT07510412
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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...
- 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
You likely can't join if
- 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...
- The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.
- people 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...
See the full eligibility criteria
Who can join
- people 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...
- 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
What rules you out
- 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.
- people 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...
- 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.
- people 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
- people 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 how well it works, or otherwise interfere with their ability to comply...
- 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.
- people receiving hemodialysis or having a creatinine level of \> 3.0mg/dL within 6 months of randomization.
- people 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.
- people 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)...
- people who are pregnant or breast-feeding.
- people with a history of poor compliance with medical treatment or who are unwilling or unable to adhere to the protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Pickerington, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pickerington, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.