Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Diabetic Foot Ulcer Clinical Trial

Official title:

Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046158
• Other study ID #: U-C-TPD-2021-01
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: ULURU Inc.
• Contact: Vaidehi Shah, MBA
• Phone: 646-431-9455
• Email: vshah[@]altrazeal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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%

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	MedStar Good Samaritan Hospital	Baltimore	Maryland
United States	VA Maryland Health Care System	Baltimore	Maryland
United States	Bronx Foot Care	Bronx	New York
United States	James J. Peters VA Medical Center	Bronx	New York
United States	Dallas Veteran's Administration Medical Center	Dallas	Texas
United States	Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390	Houston	Texas
United States	Northwell Health Wound Healing Center	Lake Success	New York
United States	MedStar Franklin Square	Rossville	Maryland
United States	VA Hudson Valley HealthCare System	Wappingers Falls	New York
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	AdventHealth Medical Group Foot & Ankle at Winter Park	Winter Park	Florida

Sponsors (3)

Lead Sponsor	Collaborator
ULURU Inc.	Military Technology Enterprise Consortium (US), Naval Medical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of wound closure	Compare rate of complete wound healing in diabetic foot wounds between the two study groups	12 weeks
Secondary	Wound healing trajectories and time to wound closure	Evaluate differences in wound healing trajectories and time to wound closure between the two study groups	12 weeks
Secondary	Adverse Events	Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections	12 weeks
Secondary	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).	12 weeks
Secondary	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.	12 weeks
Secondary	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)	12 weeks
Secondary	Clinician Acceptability	Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)	12 weeks

External Links

•   Altrazeal (Transforming Powder Dressing) product information