Diabetic Foot UlcerNCT05046158
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
A study testing Transforming Powder Dressing in people with Diabetic Foot Ulcer, run by ULURU Inc. at 12 sites in United States.
Trial summary
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Transforming Powder Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Aug 2021to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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%
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
VA Maryland Health Care System
Baltimore, Maryland, 21201-1524
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21230
Dallas Veteran's Administration Medical Center
Dallas, Texas, 75216
Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390
Houston, Texas, 77030
Northwell Health Wound Healing Center
Lake Success, New York, 11042
MedStar Franklin Square
Rossville, Maryland, 21237
Bronx Foot Care
The Bronx, New York, 10462
James J. Peters VA Medical Center
The Bronx, New York, 10468-3904
VA Hudson Valley HealthCare System
Wappingers Falls, New York, 12590
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
AdventHealth Medical Group Foot & Ankle at Winter Park
Winter Park, Florida, 32792
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Transforming Powder Dressing, Standard of care topical wound agents and dressings
- Keywords
- Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforming Powder DressingDevice
Also called Altrazeal
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.
Standard of care topical wound agents and dressingsOther
Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.
| Study group | Role | What they receive |
|---|---|---|
| Transforming Powder Dressing | Active comparator | 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. Receives: Device: Transforming Powder Dressing |
| Standard of Care Dressing | Active comparator | 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. Receives: Other: Standard of care topical wound agents and dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound closure
Compare rate of complete wound healing in diabetic foot wounds between the two study groups
Measured: 12 weeks
Secondary outcomes (6)
Wound healing trajectories and time to wound closure
Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
Measured: 12 weeks
Adverse Events
Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 12 weeks
Clinician Acceptability
Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start16 Aug 2021
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- ULURU Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Naval Medical Research Center, Military Technology Enterprise Consortium (US)
- Responsible party
- Sponsor
- Investigators
- Lawrence Lavery, DPM, MPH, Principal investigator, Altrazeal Life Sciences Inc.Jonathan Saxe, MD, Study director, Altrazeal Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046158
- Sponsor's protocol ID
- U-C-TPD-2021-01
- Status last verified
- Nov 2025
- First submitted
- 17 Aug 2021
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 32176447Han 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.
PubMed 28108895Wound 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05046158
- Acronym / sponsor ID
- U-C-TPD-2021-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- ULURU Inc.Industry (pharma, biotech, devices)
- Collaborators
- Naval Medical Research Center, Military Technology Enterprise Consortium (US)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
| Arm | Type | Receives |
|---|---|---|
| Transforming Powder Dressing | Active comparator | Device: Transforming Powder DressingHalf 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. |
| Standard of Care Dressing | Active comparator | Other: Standard of care topical wound agents and dressingsHalf 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforming Powder DressingAlso: AltrazealAltrazeal 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. | Device | Transforming Powder Dressing |
| Standard of care topical wound agents and dressingsStandard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed. | Other | Standard of Care Dressing |
Primary outcome
Incidence of wound closure
Time frame: 12 weeks
Compare rate of complete wound healing in diabetic foot wounds between the two study groups
6 secondary outcomes
Wound healing trajectories and time to wound closure
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
Subject Satisfaction
Time frame: 12 weeks
Wound pain
Time frame: 12 weeks
Quality of Life while living with a wound
Time frame: 12 weeks
Clinician Acceptability
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 32176447Schaper 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.
- Background: PubMed 28108895Han 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.
- BackgroundWound 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.
- Altrazeal (Transforming Powder Dressing) product informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Lavery, DPM, MPH principal investigator
Altrazeal Life Sciences Inc.
Jonathan Saxe, MD study director
Altrazeal Life Sciences Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforming Powder Dressing in people with Diabetic Foot Ulcer, run by ULURU Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound closure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046158, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.