COMPLETED

Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Conditions

Diabetic Foot Ulcer Standard of Care Wound Dressings Transforming Powder Dressing Diabetic Foot Ulcers Altrazeal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-08-16

Study Completion:2025-11-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05046158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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%

Inclusion Criteria

Exclusion 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.

* 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%

Contacts and Locations

Principal Investigator

Lawrence Lavery, DPM, MPH

PRINCIPAL_INVESTIGATOR

Altrazeal Life Sciences Inc.

Jonathan Saxe, MD

STUDY_DIRECTOR

Altrazeal Life Sciences Inc.

Study Locations (Sites)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010

United States

AdventHealth Medical Group Foot & Ankle at Winter Park

Winter Park, Florida, 32792

United States

VA Maryland Health Care System

Baltimore, Maryland, 21201-1524

United States

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21230

United States

MedStar Franklin Square

Rossville, Maryland, 21237

United States

Northwell Health Wound Healing Center

Lake Success, New York, 11042

United States

Bronx Foot Care

The Bronx, New York, 10462

United States

James J. Peters VA Medical Center

The Bronx, New York, 10468-3904

United States

VA Hudson Valley HealthCare System

Wappingers Falls, New York, 12590

United States

Dallas Veteran's Administration Medical Center

Dallas, Texas, 75216

United States

Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: ULURU Inc.

Lawrence Lavery, DPM, MPH, PRINCIPAL_INVESTIGATOR, Altrazeal Life Sciences Inc.
Jonathan Saxe, MD, STUDY_DIRECTOR, Altrazeal Life Sciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-16

Study Completion Date2025-11-06

Study Record Updates

Study Start Date2021-08-16

Study Completion Date2025-11-06

Terms related to this study

Keywords Provided by Researchers

Standard of Care Wound Dressings
Transforming Powder Dressing
Diabetic Foot Ulcers
Altrazeal

Additional Relevant MeSH Terms

Diabetic Foot Ulcer