Clinical trial NCT05046158: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Standard of Care Wound Dressings
Transforming Powder Dressing
Diabetic Foot Ulcers
Altrazeal
Lead sponsor: ULURU Inc.
Sponsor class: INDUSTRY
Collaborators: name: Naval Medical Research Center
name: Military Technology Enterprise Consortium (US)
First posted: 2021-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Incidence of wound closure
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound healing trajectories and time to wound closure
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 12 weeks
measure: Subject Satisfaction
timeFrame: 12 weeks
measure: Wound pain
timeFrame: 12 weeks
measure: Quality of Life while living with a wound
timeFrame: 12 weeks
measure: Clinician Acceptability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Winter Park
country: United States
facility: AdventHealth Medical Group Foot & Ankle at Winter Park
state: Florida
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
city: Rossville
country: United States
facility: MedStar Franklin Square
state: Maryland
city: Bronx
country: United States
facility: Bronx Foot Care
state: New York
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: Lake Success
country: United States
facility: Northwell Health Wound Healing Center
state: New York
city: Wappingers Falls
country: United States
facility: VA Hudson Valley HealthCare System
state: New York
city: Dallas
country: United States
facility: Dallas Veteran's Administration Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390
state: Texas
Study officials:
affiliation: Altrazeal Life Sciences Inc.
name: Lawrence Lavery, DPM, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Altrazeal Life Sciences Inc.
name: Jonathan Saxe, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.