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Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

NCT05046158 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-11-19

No results posted yet for this study

Summary

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

Conditions

  • Diabetic Foot Ulcer

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.

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Military Technology Enterprise Consortium (US)

    collaborator UNKNOWN

  • ULURU Inc.

    lead INDUSTRY

Principal Investigators

  • Lawrence Lavery, DPM, MPH · Altrazeal Life Sciences Inc.

  • Jonathan Saxe, MD · Altrazeal Life Sciences Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2025-11-06
Completion
2025-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046158 on ClinicalTrials.gov