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The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers

NCT03905863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2021-11-22

Study results available
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Summary

A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.

Conditions

  • Diabetic Foot Ulcer
  • Surgical Wound

Interventions

DEVICE

Natrox® Oxygen Wound Therapy

A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Inotec AMD Limited

    lead INDUSTRY

Principal Investigators

  • Thomas Serena · SerenaGroup, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2020-10-18
Completion
2020-10-18
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

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 NCT03905863 on ClinicalTrials.gov