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Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05046158
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : March 24, 2022
Sponsor:
Collaborators:
Naval Medical Research Center
Military Technology Enterprise Consortium (US)
Information provided by (Responsible Party):
ULURU Inc.

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Transforming Powder Dressing Other: Standard of care topical wound agents and dressings Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Incidence of wound closure [ Time Frame: 12 weeks ]
    Compare rate of complete wound healing in diabetic foot wounds between the two study groups


Secondary Outcome Measures :
  1. Wound healing trajectories and time to wound closure [ Time Frame: 12 weeks ]
    Evaluate differences in wound healing trajectories and time to wound closure between the two study groups

  2. Adverse Events [ Time Frame: 12 weeks ]
    Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections

  3. Subject Satisfaction [ Time Frame: 12 weeks ]
    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).

  4. Wound pain [ Time Frame: 12 weeks ]
    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.

  5. Quality of Life while living with a wound [ Time Frame: 12 weeks ]
    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)

  6. Clinician Acceptability [ Time Frame: 12 weeks ]
    Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05046158


Contacts
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Contact: Vaidehi Shah, MBA 646-431-9455 vshah@uluruinc.com
Contact: Susan St. John, MSN, APRN-NP 412-303-5379 sstjohn@uluruinc.com

Locations
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United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Theresa Moriarty, MSN    202-877-3657    Theresa.M.Moriarty@medstar.net   
Contact: Kendra S Green    202-887-5819    Kendra.S.Green@medstar.net   
Principal Investigator: Kenneth L Fan, MD         
Sub-Investigator: Christopher E Attinger, MD         
Sub-Investigator: John Steinberg, DPM         
Sub-Investigator: Caitlin Zarick, DPM         
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Theresa Moriarty, MSN    202-877-3657    Theresa.M.Moriarty@medstar.net   
Contact: Kendra Green    202-877-5819    Kendra.s.green@medstar.net   
Principal Investigator: Michelle Magee, MD         
Sub-Investigator: Ali Vaghef, DPM         
Sub-Investigator: Caitlin S Zarick, DPM         
United States, Florida
AdventHealth Medical Group Foot & Ankle at Winter Park Recruiting
Winter Park, Florida, United States, 32792
Contact: Cristina Santiago    407-657-9188    Cristina.santiago@adventhealth.com   
Contact: Leticia Valentin       leticia.valentin@adventhealth.com   
Principal Investigator: Gerald Bornstein, DPM         
Sub-Investigator: Shane Amber, DPM         
Sub-Investigator: Christopher Reeves, DPM         
United States, Maryland
MedStar Good Samaritan Hospital Recruiting
Baltimore, Maryland, United States, 21230
Contact: Terry Moriarty, MSN, CCRN    202-801-2420    Theresa.M.Moriarty@medstar.net   
Contact: Mia Hamm    443-444-6275    Mia.A.Hamm@medstar.net   
Principal Investigator: David Z Martin, MD         
MedStar Franklin Square Recruiting
Rossville, Maryland, United States, 21237
Contact: Cynthia Yashinski       Cynthia.L.Yashinski@medstar.net   
Principal Investigator: Kenneth L Fan, MD         
Sub-Investigator: Paul Carroll, MD         
Sub-Investigator: Tiffany Hoh, DPM         
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468-3904
Contact: Jonathan Allen, PA    718-584-9000    Jonathan.allen@va.gov   
Contact: Johane Simelane, MPH    718-584-9000 ext 6671    Johane.Simelane@va.gov   
Principal Investigator: Rajiv Chander, MD         
Northwell Health Wound Healing Center Active, not recruiting
Lake Success, New York, United States, 11042
United States, Texas
Dallas Veteran's Administration Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: David Truong, DPM, MS    214-857-0039    David.Truong1@va.gov   
Contact: Cassie Lusk       cassie.lusk@va.gov   
Principal Investigator: David Truong, DPM         
Sponsors and Collaborators
ULURU Inc.
Naval Medical Research Center
Military Technology Enterprise Consortium (US)
Investigators
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Principal Investigator: Lawrence Lavery, DPM, MPH ULURU Inc.
Additional Information:
Publications:
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Responsible Party: ULURU Inc.
ClinicalTrials.gov Identifier: NCT05046158    
Other Study ID Numbers: U-C-TPD-2021-01
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ULURU Inc.:
Standard of Care Wound Dressings
Transforming Powder Dressing
Diabetic Foot Ulcers
Altrazeal
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases