Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

ULURU Inc.

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Device: Transforming Powder Dressing; Other: Standard of care topical wound agents and dressings

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; Other

Identifiers

NCT05046158

U-C-TPD-2021-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Transforming Powder Dressing

Active Comparator group

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.

Treatment:

Device: Transforming Powder Dressing

Standard of Care Dressing

Active Comparator group

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.

Treatment:

Other: Standard of care topical wound agents and dressings