Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

NCT04755647 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-31

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Nitric Oxide-Releasing Solution

Active antimicrobial

DRUG

Saline solution, hypotonic

Placebo

Sponsors & Collaborators

  • Sanotize Research and Development corp.

    lead INDUSTRY

Principal Investigators

  • Scott Schumacher, MD · Achilles Foot Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2023-05-20
Completion
2023-05-20

Countries

  • Canada

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 NCT04755647 on ClinicalTrials.gov