Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Overview

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

Full Title of Study: “Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of wound closure
    • Time Frame: 12 weeks
    • Compare rate of complete wound healing in diabetic foot wounds between the two study groups

Secondary Measures

  • Wound healing trajectories and time to wound closure
    • Time Frame: 12 weeks
    • Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
  • Adverse Events
    • Time Frame: 12 weeks
    • Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
  • Subject Satisfaction
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 12 weeks
    • Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)

Participating in This Clinical Trial

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%

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ULURU Inc.
  • Collaborator
    • Naval Medical Research Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lawrence Lavery, DPM, MPH, Principal Investigator, Altrazeal Life Sciences Inc.
    • Jonathan Saxe, MD, Study Director, Altrazeal Life Sciences Inc.
  • Overall Contact(s)
    • Vaidehi Shah, MBA, 646-431-9455, vshah@altrazeal.com

References

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.

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.

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.

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