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Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transforming Powder Dressing
Standard of care topical wound agents and dressings
Sponsored by
ULURU Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • MedStar Georgetown University HospitalRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • AdventHealth Medical Group Foot & Ankle at Winter Park
  • VA Maryland Health Care System
  • MedStar Good Samaritan HospitalRecruiting
  • MedStar Franklin SquareRecruiting
  • Bronx Foot CareRecruiting
  • James J. Peters VA Medical CenterRecruiting
  • Northwell Health Wound Healing CenterRecruiting
  • VA Hudson Valley HealthCare System
  • Dallas Veteran's Administration Medical CenterRecruiting
  • Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transforming Powder Dressing

Standard of Care Dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of wound closure
Compare rate of complete wound healing in diabetic foot wounds between the two study groups

Secondary Outcome Measures

Wound healing trajectories and time to wound closure
Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
Adverse Events
Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
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).
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.
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)
Clinician Acceptability
Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)

Full Information

First Posted
August 17, 2021
Last Updated
June 27, 2023
Sponsor
ULURU Inc.
Collaborators
Naval Medical Research Center, Military Technology Enterprise Consortium (US)
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1. Study Identification

Unique Protocol Identification Number
NCT05046158
Brief Title
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Official Title
Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ULURU Inc.
Collaborators
Naval Medical Research Center, Military Technology Enterprise Consortium (US)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transforming Powder Dressing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care Dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transforming Powder Dressing
Other Intervention Name(s)
Altrazeal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care topical wound agents and dressings
Intervention Description
Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.
Primary Outcome Measure Information:
Title
Incidence of wound closure
Description
Compare rate of complete wound healing in diabetic foot wounds between the two study groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wound healing trajectories and time to wound closure
Description
Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
Time Frame
12 weeks
Title
Adverse Events
Description
Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
Time Frame
12 weeks
Title
Subject Satisfaction
Description
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).
Time Frame
12 weeks
Title
Wound pain
Description
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.
Time Frame
12 weeks
Title
Quality of Life while living with a wound
Description
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)
Time Frame
12 weeks
Title
Clinician Acceptability
Description
Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vaidehi Shah, MBA
Phone
646-431-9455
Email
vshah@altrazeal.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan St. John, MSN, APRN-NP
Phone
412-303-5379
Email
sstjohn@altrazeal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Lavery, DPM, MPH
Organizational Affiliation
Altrazeal Life Sciences Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Saxe, MD
Organizational Affiliation
Altrazeal Life Sciences Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Moriarty, MSN
Phone
202-877-3657
Email
Theresa.M.Moriarty@medstar.net
First Name & Middle Initial & Last Name & Degree
Katie S Church
Phone
202-887-5819
Email
katherine.e.church@medstar.net
First Name & Middle Initial & Last Name & Degree
Kenneth L Fan, MD
First Name & Middle Initial & Last Name & Degree
Christopher E Attinger, MD
First Name & Middle Initial & Last Name & Degree
John Steinberg, DPM
First Name & Middle Initial & Last Name & Degree
Caitlin Zarick, DPM
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Moriarty, MSN
Phone
202-877-3657
Email
Theresa.M.Moriarty@medstar.net
First Name & Middle Initial & Last Name & Degree
Church Katie
Phone
202-877-5819
Email
katherine.e.church@medstar.net
First Name & Middle Initial & Last Name & Degree
Michelle Magee, MD
First Name & Middle Initial & Last Name & Degree
Ali Vaghef, DPM
First Name & Middle Initial & Last Name & Degree
Caitlin S Zarick, DPM
Facility Name
AdventHealth Medical Group Foot & Ankle at Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Completed
Facility Name
VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1524
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MedStar Good Samaritan Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Moriarty, MSN, CCRN
Phone
202-801-2420
Email
Theresa.M.Moriarty@medstar.net
First Name & Middle Initial & Last Name & Degree
Mia Hamm
Phone
443-444-6275
Email
Mia.A.Hamm@medstar.net
First Name & Middle Initial & Last Name & Degree
David Z Martin, MD
Facility Name
MedStar Franklin Square
City
Rossville
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Yashinski
Email
Cynthia.L.Yashinski@medstar.net
First Name & Middle Initial & Last Name & Degree
Kenneth L Fan, MD
First Name & Middle Initial & Last Name & Degree
Paul Carroll, MD
First Name & Middle Initial & Last Name & Degree
Tiffany Hoh, DPM
Facility Name
Bronx Foot Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Castillo, DPM
Phone
718-792-5900
Email
dr.castillo@nysdpm.com
First Name & Middle Initial & Last Name & Degree
Brian Alvear
Phone
718-792-5900
Email
b.alvear@nysdpm.com
First Name & Middle Initial & Last Name & Degree
Oscar Castillo, DPM
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Allen, PA
Phone
718-584-9000
Email
Jonathan.allen@va.gov
First Name & Middle Initial & Last Name & Degree
Katherine Bolanos Roldan, MPH
Phone
718-584-9000
Ext
5776
Email
Katherine.BolanosRoldan@va.gov
First Name & Middle Initial & Last Name & Degree
Rajiv Chander, MD
Facility Name
Northwell Health Wound Healing Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Kaplan, RN
Phone
516-233-3781
Email
Skaplan2@northwell.edu
First Name & Middle Initial & Last Name & Degree
Farisha Baksh
Phone
516 233 3781
Email
fbaksh@northwell.edu
First Name & Middle Initial & Last Name & Degree
Alisha Oropallo, MD
First Name & Middle Initial & Last Name & Degree
Christina Del Pin, MD
First Name & Middle Initial & Last Name & Degree
Michael Persico, MD
First Name & Middle Initial & Last Name & Degree
Russell Caprioli, DPM
First Name & Middle Initial & Last Name & Degree
John Haight, DPM
First Name & Middle Initial & Last Name & Degree
Michael Pliskin, DPM
First Name & Middle Initial & Last Name & Degree
Scott Gawlik, DPM
First Name & Middle Initial & Last Name & Degree
Julie Isgro, NP
Facility Name
VA Hudson Valley HealthCare System
City
Wappingers Falls
State/Province
New York
ZIP/Postal Code
12590
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rindner, DPM
Phone
845-831-2000
Ext
215663
Email
Daniel.Rindner@va.gov
First Name & Middle Initial & Last Name & Degree
Kathleen Escoto
Phone
845-831-2000
Email
Kathleen.Escoto@va.gov
First Name & Middle Initial & Last Name & Degree
Daniel Rindner, MD
First Name & Middle Initial & Last Name & Degree
Justine Moran, DPM
Facility Name
Dallas Veteran's Administration Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Truong, DPM, MS
Phone
214-857-0039
Email
David.Truong1@va.gov
First Name & Middle Initial & Last Name & Degree
Cassie Lusk
Email
cassie.lusk@va.gov
First Name & Middle Initial & Last Name & Degree
David Truong, DPM
Facility Name
Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
Phone
713-798-7536
Email
najafi@bcm.edu
First Name & Middle Initial & Last Name & Degree
Alejandro Rojas y Zulbaran
Email
alejandro.zulbaranyrojas@bcm.edu
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
First Name & Middle Initial & Last Name & Degree
Jayer Chung, MD, MSc
First Name & Middle Initial & Last Name & Degree
Jeffrey Ross, MD, DPM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32176447
Citation
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.
Results Reference
background
PubMed Identifier
28108895
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
http://www.Altrazeal.info
Description
Altrazeal (Transforming Powder Dressing) product information

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Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

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