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NCT03863054

An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers

Completed Last updated 27 September 2021
What this trial tests

trial testing NATROX™ Topical Oxygen Therapy System in Diabetic Foot Ulcer in 20 participants. Completed in 31 May 2021.

Timeline
17 August 2018
Primary endpoint
23 March 2021
31 May 2021

Quick facts

Lead sponsorSingapore General Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date17 August 2018
Primary completion23 March 2021
Estimated completion31 May 2021
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

Singapore General Hospital

Who can join

Adults 21 to 90, any sex, with Diabetic Foot Ulcer or Non-healing Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks. If the wound is not reduced by more than 40%, NATROX™ will be applied for the next 12 weeks. Throughout the study period, wound measurements will be taken to measure wound reduction.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products.
    Sharma A, Sharma D, Zhao F. · · 2023 · cited 29× · PMID 37306401 · DOI 10.1002/adhm.202300556
  2. An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (Natrox<sup>™</sup>) on the Rates of Healing of Chronic DiAbetic Foot Ulcers (OTONAL Trial).
    Tang TY, Mak MYQ, Yap CJQ, Boey JEC, et al · · 2024 · cited 13× · PMID 34747267 · DOI 10.1177/15347346211053694
  3. Advances in nucleic acid delivery strategies for diabetic wound therapy.
    Sarthi S, Bhardwaj H, Kumar Jangde R. · · 2024 · cited 4× · PMID 39286540 · DOI 10.1016/j.jcte.2024.100366

Verify or expand the search:

Other recruiting trials for Diabetic Foot Ulcer

Currently open trials in the same condition.

Other Singapore General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03863054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing