Is NCT05496296 recruiting in Baltimore, MD?

Yes, NCT05496296 is currently recruiting participants at its Baltimore, MD location. This pressure ulcers stage ii clinical trial is actively enrolling qualified participants.

How do I join the pressure ulcers stage ii clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pressure Ulcers Stage II Clinical Trial in Baltimore, MD

About This Pressure Ulcers Stage II Study in Baltimore

Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.

Sponsor: ULURU Inc.

Who Can Participate

Inclusion Criteria

18 to 85 years of age;

Stage 2, 3, or 4 Pressure Injuries;

Wound exudate is mild to moderate;

No clinically active wound infection (clinical diagnosis);

Able and willing to provide written (not proxy) informed consent;

Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.

Exclusion Criteria

Known allergy or hypersensitivity to TPD or its components;

Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;

Heavily exudative wounds;

Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema \>0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;

Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months);

Body Mass Index (BMI) \>45 kg/m2;

Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);

Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb);

Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;

Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;

Wounds with necrosis unable to undergo prior definitive debridement;

Active gangrene;

Untreated HIV;

Currently pregnant or lactating;

Impending organ transplant;

Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;

Unwilling or unable to comply with offloading recommendations;

If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:

Unable to keep research appointments;

Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);

Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;

Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;

Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;

Not suitable for study participation. -

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 Baltimore?

Yes, this clinical trial (NCT05496296) has an active research site in Baltimore, MD 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.

Pressure Ulcers Stage II Treatment Options in Baltimore, MD

If you're searching for pressure ulcers stage ii treatment options in Baltimore, MD, this clinical trial (NCT05496296) 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 Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pressure ulcers stage ii 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.

Looking for more options? Browse all pressure ulcers stage ii clinical trials near you to find additional studies recruiting in your area.

Pressure Ulcers Stage II Clinical Trial in Baltimore, MD

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