Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

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.

开始日期2023-04-30

申办/合作机构

ULURU, Inc.

[+1]

NCT05424354

/ Recruiting临床4期

Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds

This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.

开始日期2022-05-26

申办/合作机构

ULURU, Inc.

NCT05046158

/ CompletedN/A

Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers

Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.

开始日期2021-08-16

申办/合作机构

ULURU, Inc.

[+1]

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项与 ULURU, Inc. 相关的文献（医药）

2025-09-01·MILITARY MEDICINE

Innovative Technique for Wound Management in Combat Zones and Low-Resource Settings: A Mission-Oriented Project for Treating Traumatic Wounds

Article

作者: St. John, Susan ; Saxe, Jonathan

Abstract:

Introduction:

Caregivers encounter significant challenges when managing traumatic wounds, especially in resource-limited settings. Frequent dressing changes consume substantial resources, worsen complications such as pain and infection, and contribute to prolonged healing times. Despite advancements in wound care, these issues persist globally, highlighting the urgent need for innovative solutions. This study evaluated the efficacy of an extended-wear transforming powder dressing (TPD) for treating traumatic wounds in a low-resource setting.

Materials and Methods:

Altrazeal Life Sciences Inc., in collaboration with the Austrian Development Agency, led a mission-oriented humanitarian project to treat as many patients as possible over a one-year period in resource-constrained public hospitals across India. The project focused on implementing TPD in overburdened facilities to enhance wound healing outcomes and improve resource efficiency in real-world, low-resource settings. After receiving an Institutional Review Board exemption, the study team extracted deidentified project data for a subset of all patients with traumatic wounds (n = 39) to evaluate the efficacy of TPD.

Results:

All patients who completed at least 2 visits were included in the final analysis (n = 23). The cohort consisted of 70% males, with a median age of 40 years (range: 8-82), a median wound duration of 30 days (range: 5-120), and a median wound area of 51.3 cm2 (range: 7-600). All patients demonstrated marked clinical improvement, regardless of wound etiology, initial condition, or duration, achieving a median wound area reduction of 51% over a median of 16 days of TPD treatment. Thirty-nine percent of patients healed or were discharged, achieving a 79% median reduction in wound area with a median treatment duration of 31 days. The remaining 61% successfully underwent skin grafting, with a median wound area reduction of 24% after 14 days of TPD treatment. Patients treated with TPD required a median of 1.8 dressing changes per week, compared to 7 with standard care before conversion, resulting in a 75% reduction in dressing change frequency.

Conclusions:

Patients treated with TPD showed marked wound area reduction in all trauma wounds with significant overall reduction in dressing change frequency and required time and materials relative to standard of care.

项与 ULURU, Inc. 相关的新闻（医药）

2013-08-09

·BioSpace

ULURU Inc. Announces Conference Call to Discuss Financial Results For the Second Quarter Ended June 30, 2013

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today! ADDISON, Texas, Aug. 9, 2013 /PRNewswire/ -- ULURU Inc. (OTCQB: ULUR) today announced that it has scheduled a conference call to discuss the second quarter ended June 30, 2013 financial results and to provide a general business update on Thursday, August 15, 2013 at 9:00 a.m. Eastern Time. To participate in the conference call please dial (800) 357-0498, for international callers dial (850) 429-1388 (access code 24013#) five to ten minutes prior to the initiation of the teleconference. If you are unable to listen to the live broadcast, a replay of the call will be available starting on August 15, 2013 two hours following the end of the call until August 29, 2013 at 11:59 p.m. Eastern Time. For the U.S. replay, please dial (866) 415-9493 and international callers please dial (205) 289-3247 (access code 24013#). You may also access the replay of the call two hours following the end of the call until August 29, 2013 at 11:59 p.m. Eastern Time via the web by logging onto . About ULURU Inc.: ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers with improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex® Aggregate technology and OraDisc transmucosal delivery system. For more information about ULURU Inc., please visit . For more information about Altrazeal®, please visit . This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended. These statements are subject to numerous risks and uncertainties, including but not limited to the risk factors detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2012 and other reports filed by us with the Securities and Exchange Commission. Contact: Company Kerry P. Gray President & CEO Terry K. Wallberg Vice President & CFO (214) 905-5145 SOURCE ULURU Inc. Hey, check out all the engineering jobs. Post your resume today!

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