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

Diabetic Foot Ulcer Clinical Trial

Official title:
A Randomized Controlled Multicentre Trial, Examining the Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers

Clinical Trial Summary

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

Clinical Trial Description

Patients with diabetic foot ulcers will be enrolled into the trial at multiple wound care centers and hospital research centers across the United States of America. After qualifying per protocol, patients will be randomized to receive standard wound care or standard wound care plus Topical Oxygen Wound Therapy for their wounds. Patients will be monitored for 12 weeks. The primary comparator between the groups will be complete wound healing at 12 weeks, but other parameters will be assessed, such as pain, wound size reduction and infection status. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03905863
Study type Interventional
Source Inotec AMD Limited
Contact
Status Completed
Phase N/A
Start date June 4, 2019
Completion date October 18, 2020
View Details
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