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New powder dressing shows promise for healing diabetic foot sores

NCT ID NCT05046158

Disease control Sponsor: ULURU Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special powder dressing against standard wound care for healing diabetic foot ulcers in 135 adults with diabetes. The powder aims to help wounds close faster. Researchers measured how many ulcers fully healed and how quickly, while also checking for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

135 people

The number who actually took part.

Started

Aug 2021

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18-89 years old * Diagnosed with diabetes Mellitus; hemoglobin A1C \< 12% * Diabetic foot ulcer present for minimum 30 days (Wagner grade 1 or 2 classification) * Wound drainage is minimal or moderate * No clinically active wound infection * Able and willing to provide consent * Has not participated in another research trial within 3 months of enrollment. Exclusion Criteria: * Unable to keep weekly research appointments * Unable or unwilling to use offloading device if recommended * Wounds with large amount (high) drainage * Active gangrene * Wounds impending surgical intervention (including revascularization or plastic surgery) * Untreated osteomyelitis * Soft tissue infection (can be enrolled once infection is cleared) * Active Charcot arthropathy * BMI \>45kg/m2 * History of AIDS * History of organ transplant or impending transplant * End stage renal disease requiring dialysis * Decompensated hepatic or cardiac disease * Select autoimmune diseases * Lymphedema * Oral steroid use in last 3 months * Venous stasis disease * Active malignancy (cancer) * Unable to sign consent * Active alcohol or substance abuse * Pregnant or lactating women * Insufficient vascular flow to heal a wound * Hemoglobin A1C \>12%

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

Contacts and locations

Locations

  • AdventHealth Medical Group Foot & Ankle at Winter Park

    Winter Park, Florida, 32792, United States

  • Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390

    Houston, Texas, 77030, United States

  • Bronx Foot Care

    The Bronx, New York, 10462, United States

  • Dallas Veteran's Administration Medical Center

    Dallas, Texas, 75216, United States

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468-3904, United States

  • MedStar Franklin Square

    Rossville, Maryland, 21237, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21230, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Northwell Health Wound Healing Center

    Lake Success, New York, 11042, United States

  • VA Hudson Valley HealthCare System

    Wappingers Falls, New York, 12590, United States

  • VA Maryland Health Care System

    Baltimore, Maryland, 21201-1524, United States

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