Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Transforming Powder Dressing; Other: Standard of care topical wound agents and dressings

Detailed Description

Diabetic men and women aged 18-89 years, who have a diabetic foot ulcer present for a minimum of 30 days will be considered for the study. Subjects will be randomized to either standard of care wound dressings or transforming powder dressing. Half of the subjects will receive standard of care dressings, and the other half will receive transforming powder dressing in a 1:1 randomization process at each of the study sites. Subjects will present to the study center weekly for up to 12 weeks (less time if the wound heals prior to 12 weeks). The last study visit occurs 12 weeks after the End of Study visit.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Winter Park, Florida, United States, 32792
      • AdventHealth Medical Group Foot & Ankle at Winter Park
  • Maryland
    • Baltimore, Maryland, United States, 21201-1524
      • VA Maryland Health Care System
    • Baltimore, Maryland, United States, 21230
      • MedStar Good Samaritan Hospital
    • Rossville, Maryland, United States, 21237
      • MedStar Franklin Square
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health Wound Healing Center
    • The Bronx, New York, United States, 10462
      • Bronx Foot Care
    • The Bronx, New York, United States, 10468-3904
      • James J. Peters VA Medical Center
    • Wappingers Falls, New York, United States, 12590
      • VA Hudson Valley Healthcare System
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas Veteran's Administration Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transforming Powder Dressing; 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.	Device: Transforming Powder Dressing; Altrazeal transforming powder dressing is methacrylate-based powder dressing made from the same materials used in the production of contact lenses. Upon hydration, the powder transforms into a moist, non-occlusive barrier that covers and protects the wound from exogenous bacteria while helping manage exudate through vapor transpiration.; Other Names: Altrazeal
Active Comparator: Standard of Care Dressing; 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.	Other: Standard of care topical wound agents and dressings; Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of wound closure	Compare rate of complete wound healing in diabetic foot wounds between the two study groups	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing trajectories and time to wound closure	Evaluate differences in wound healing trajectories and time to wound closure between the two study groups	12 weeks
Adverse Events	Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections	12 weeks
Subject Satisfaction	Evaluate subject satisfaction of wound care products based on "Research subject satisfaction survey" completed at the end of study (8 questions total using a 7 point Likert scale).	12 weeks
Wound pain	Compare differences in pain between the groups based on results of a validated 10 point "Visual Analogue Pain Scale" completed at each visit by all subjects. More pain is indicated by higher scores.	12 weeks
Quality of Life while living with a wound	Compare differences in quality of life between the groups based on results of completed validated "Wound Quality of Life Questionnaire for Chronic Wounds" (17 questions total, answering a 5 point scale [not at all to very much], results from answers based on formula)	12 weeks
Clinician Acceptability	Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)	12 weeks

Collaborators and Investigators

• Sponsor: ULURU Inc.
• Collaborators: Naval Medical Research Center; Military Technology Enterprise Consortium (US)
• Investigators: Principal Investigator: Lawrence Lavery, DPM, MPH, Altrazeal Life Sciences Inc.; Study Director: Jonathan Saxe, MD, Altrazeal Life Sciences Inc.

Publications and helpful links

General Publications

• Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.
• Han G, Ceilley R. Chronic Wound Healing: A Review of Current Management and Treatments. Adv Ther. 2017 Mar;34(3):599-610. doi: 10.1007/s12325-017-0478-y. Epub 2017 Jan 21.
• Wound Care Awareness Week Highlights of the Chronic Wound Epidemic in U.S. Businesswire.com/news/home/20160607006326/en/Wound-Care-Awareness-Week-Highlights-Chronic-Wound. Accessed 11/5/2020.

Helpful Links

• Altrazeal (Transforming Powder Dressing) product information

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcers; Standard of Care Wound Dressings; Transforming Powder Dressing; Altrazeal
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot; Equipment and Supplies; Bandages
• Other Study ID Numbers: U-C-TPD-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes