Last updated: June 27, 2023
Sponsor: ULURU Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pressure Ulcer
Treatment
Altrazeal® Transforming Powder Dressing
Clinical Study ID
NCT05496296
U-C-TPD-2022-01
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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: localswelling or in duration, erythema >0.5cm around the ulcer in any direction, localtenderness 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 thelimb);
- Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on theaffected limb, if wound is located on the limb);
- Received immunosuppression or biologics in the last six weeks and/or is expected toreceive 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) duringstudy period that may impact study outcomes;
- Wounds with necrosis unable to undergo prior definitive debridement;
- Fistulas;
- 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 forthis study because:
- Unable to keep research appointments;
- Poorly controlled incontinence which may impact study outcomes (e.g., dependingon the location of the wound);
- Participated in another investigative study within 3 months of enrollment thatcould interfere with study outcomes;
- Active alcohol or substance abuse (cocaine, heroin, or other substances) that mayinterfere with healing or subject compliance with visit schedules;
- Concurrent clinical condition(s) that could pose a health risk to patient orinfluence outcome of study;
- Not suitable for study participation. -
Study Design
Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Altrazeal® Transforming Powder Dressing
Phase:
Study Start date:
April 30, 2023
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Northwestern Medicine
Chicago, Illinois 60611
United StatesActive - Recruiting
James J. Peters VA Medical Center
Bronx, New York 10468
United StatesActive - Recruiting
NYU Langone Hospital-Long Island
Mineola, New York 11501
United StatesActive - Recruiting
University of Pittsburgh Medical Center (UPMC) Presbyterian
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
VA North Texas Healthcare System
Dallas, Texas 75243
United StatesSite Not Available
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