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Wound Dressing

Transforming Powder Dressing vs Standard Care for Foot Ulcer

N/A
Recruiting
Led By Lawrence Lavery, DPM, MPH
Research Sponsored by ULURU Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Wound drainage is minimal or moderate
Able and willing to provide consent
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial compares a new powder dressing to the standard treatment for healing diabetic foot ulcers.

Who is the study for?
This trial is for adults aged 18-89 with diabetes and a diabetic foot ulcer that's lasted at least 30 days. They should have controlled blood sugar (Hemoglobin A1C <12%) and be able to attend weekly appointments. People with severe illnesses, high BMI (>45), recent steroid use, or heavy wound drainage cannot participate.Check my eligibility
What is being tested?
The study compares a new Transforming Powder Dressing against standard care dressings in healing diabetic foot ulcers. It's a Phase IV trial where participants are randomly chosen to receive one of the treatments and monitored over time.See study design
What are the potential side effects?
While specific side effects aren't listed, typical risks may include skin irritation, allergic reactions to dressing materials, or infection due to improper wound management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of wound closure
Secondary outcome measures
Adverse Events
Clinician Acceptability
Quality of Life while living with a wound
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Standard of Care DressingActive Control1 Intervention
Half of the subjects will be randomized to receive standard of care wound dressings to treat their diabetic foot ulcers. Wounds will be evaluated weekly, debrided if needed, photographed, and measured. A wound dressing will be applied using standard of care wound products, and the wound will be offloaded when necessary (pressure taken off of the wound using a total contact cast or other device). Wound healing progress will be monitored and compared to transforming powder dressings used to treat diabetic foot ulcers. Surveys regarding pain and quality of life will be completed at each study visit.
Group II: Transforming Powder DressingActive Control1 Intervention
Half of the subjects will be randomized to Transforming Powder Dressing to treat their diabetic foot ulcers. Wounds will be evaluated weekly, debrided if needed, photographed, and measured. A wound dressing will be applied using Transforming Powder Dressing and the wound will be offloaded when necessary (pressure taken off of the wound using a total contact cast or other device). Wound healing progress will be monitored and compared to other standard of care dressings used to treat diabetic foot ulcers.Surveys regarding pain and quality of life will be completed at each study visit.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Military Technology Enterprise Consortium (US)UNKNOWN
ULURU Inc.Lead Sponsor
4 Previous Clinical Trials
403 Total Patients Enrolled
Naval Medical Research CenterFED
33 Previous Clinical Trials
2,700 Total Patients Enrolled

Media Library

Standard of care topical wound agents and dressings (Wound Dressing) Clinical Trial Eligibility Overview. Trial Name: NCT05046158 — N/A
Foot Ulcer Research Study Groups: Standard of Care Dressing, Transforming Powder Dressing
Foot Ulcer Clinical Trial 2023: Standard of care topical wound agents and dressings Highlights & Side Effects. Trial Name: NCT05046158 — N/A
Standard of care topical wound agents and dressings (Wound Dressing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046158 — N/A
Foot Ulcer Patient Testimony for trial: Trial Name: NCT05046158 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the submission window for this experiment still accessible?

"Affirmative. Clinicaltrials.gov has the most up-to-date information, which confirms that this trial launched on August 16th 2021 and is actively seeking 200 patients from 10 sites for participation."

Answered by AI

How many sites are in charge of this experiment?

"The medical trial is currently enrolling individuals from 10 different sites, including Bronx Foot Care in Wappingers Falls, VA Hudson Valley HealthCare System in Houston and Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390 in Washington. There are also other locations participating across the country."

Answered by AI

Does this clinical trial offer participation to individuals below the age of twenty-five?

"This clinical trial is open to adults aged 18-89. For minors, there are 56 studies and 356 opportunities for senior citizens."

Answered by AI

Is there a cap on the amount of participants in this trial?

"To ensure the successful execution of this trial, 200 suitable individuals are needed. ULURU Inc., is spearheading the project and enlisting patients from Bronx Foot Care (Wappingers Falls, Texas) as well as VA Hudson Valley HealthCare System (Houston, District of Columbia)."

Answered by AI

What are the eligibility requirements to take part in this medical experiment?

"This medical study is looking to include 200 individuals with foot ulcer and aged between 18-89."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
James J. Peters VA Medical Center
Northwell Health Wound Healing Center
Other
MedStar Georgetown University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

working in Almenara Hospital Lima Peru. I've tried wound care center. Also Podiatrist. Even hospital. Can't get it healed.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
2021. "Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05046158.
~55 spots leftby Apr 2025
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