Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Sponsor

ULURU Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05046158

Collaborator

Naval Medical Research Center (U.S. Fed), Military Technology Enterprise Consortium (US) (Other)

200

Enrollment

Locations

Arms

12.5

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Device: Transforming Powder Dressing Other: Standard of care topical wound agents and dressings	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, InterventionalRandomized, 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 :

Aug 16, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of wound closure [12 weeks]
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 [12 weeks]
Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
Adverse Events [12 weeks]
Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
Subject Satisfaction [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).
Wound pain [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.
Quality of Life while living with a wound [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)
Clinician Acceptability [12 weeks]
Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
2	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
3	AdventHealth Medical Group Foot & Ankle at Winter Park	Winter Park	Florida	United States	32792
4	MedStar Good Samaritan Hospital	Baltimore	Maryland	United States	21230
5	MedStar Franklin Square	Rossville	Maryland	United States	21237
6	James J. Peters VA Medical Center	Bronx	New York	United States	10468-3904
7	Northwell Health Wound Healing Center	Lake Success	New York	United States	11042
8	Dallas Veteran's Administration Medical Center	Dallas	Texas	United States	75216