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A Controlled Prospective Treatment Study to Evaluate the Efficacy of Vendaje.

NCT06150209 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-29

No results posted yet for this study

Summary

The Goal of this study is to evaluate the wound volume reduction rate and the time to closure when using Vendaje to manage diabetic wounds.

The participants will be treated weekly for up to 12 weeks.

The data will be compared to retrospective Standard of care data from similarly controlled studies

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Vendaje

Dehydrated Human Amniotic Membrane

Sponsors & Collaborators

  • BioStem Technologies

    lead INDUSTRY

Principal Investigators

  • John Starinski, DPM · BioStem Technologies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-12-15
Completion
2025-06-15

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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 NCT06150209 on ClinicalTrials.gov