MedTrace Logo

Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

NCT05586542 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-12-27

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety. A total of twenty-four (24) participants will be randomized to receive up to four (4) consecutive weeks of treatment with either standard of care (SOC), plasma film + SOC, or plasma film containing silver microparticles (DERMASEAL) + SOC, with a final follow-up visit 12 weeks after the last treatment.

Conditions

  • Foot Ulcer, Diabetic

Interventions

COMBINATION_PRODUCT

DERMASEAL

a novel skin substitute formulated as planar, thin film

BIOLOGICAL

Plasma Film

a planar, thin film made from human plasma

OTHER

Standard of Care

standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment

Sponsors & Collaborators

  • Vitruvian Medical Devices, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2025-03-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05586542 on ClinicalTrials.gov