Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Description

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

Conditions

Diabetic Foot Ulcer

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Washington

MedStar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Winter Park

AdventHealth Medical Group Foot & Ankle at Winter Park, Winter Park, Florida, United States, 32792

Baltimore

VA Maryland Health Care System, Baltimore, Maryland, United States, 21201-1524

Baltimore

MedStar Good Samaritan Hospital, Baltimore, Maryland, United States, 21230

Rossville

MedStar Franklin Square, Rossville, Maryland, United States, 21237

Bronx

Bronx Foot Care, Bronx, New York, United States, 10462

Bronx

James J. Peters VA Medical Center, Bronx, New York, United States, 10468-3904

Lake Success

Northwell Health Wound Healing Center, Lake Success, New York, United States, 11042

Wappingers Falls

VA Hudson Valley HealthCare System, Wappingers Falls, New York, United States, 12590

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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%

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ULURU Inc.,

Lawrence Lavery, DPM, MPH, PRINCIPAL_INVESTIGATOR, Altrazeal Life Sciences Inc.

Jonathan Saxe, MD, STUDY_DIRECTOR, Altrazeal Life Sciences Inc.

Study Record Dates

2023-12-31