← Back to Search

Nitric Oxide-Releasing Solution for Foot Ulcer

Phase 1 & 2
Waitlist Available
Led By Scott Schumacher, MD
Research Sponsored by Sanotize Research and Development corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days
Awards & highlights

Study Summary

This trial will study whether a nitric oxide releasing solution can help heal foot ulcers for people with diabetes.

Eligible Conditions
  • Diabetic Foot Ulcers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure the methemoglobin percent level during NORS compared to hypotonic saline administration in participants withe DFU
To measure the negative changes in laboratory values of NORS compared to hypotonic saline with DFU
To measure the negative changes in vital sign during NORS compared to hypotonic saline administration in participants with DFU
+4 more
Secondary outcome measures
To measure the efficacy of NORS compared to placebo on the change in bacterial load (CFU/mL) in participants with DFU
To measure the efficacy of NORS compared to placebo on the change in pathogen load in participants with DFU
To measure the efficacy of NORS compared to placebo on the change in wound area in participants with DFU
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitric Oxide-Releasing Solution (NORS)Experimental Treatment1 Intervention
Five litre foot bath delivery NORS
Group II: SalinePlacebo Group1 Intervention
Five litre foot bath delivery NORS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide-Releasing Solution
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Sanotize Research and Development corp.Lead Sponsor
8 Previous Clinical Trials
2,120 Total Patients Enrolled
Scott Schumacher, MDPrincipal InvestigatorAchilles Foot Health Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this clinical research project?

"Affirmative, clinicaltrials.gov data demonstrates that this experiment is currently enrolling participants. It was initially advertised on February 23rd 2021 and its details have been most recently adjusted on October 27th 2022. The trial requires 40 individuals to be recruited at a single medical centre."

Answered by AI

How many individuals are able to partake in this clinical exploration?

"Affirmative. Information located on clinicaltrials.gov confirms that this research is proceeding and looking to recruit 40 patients from 1 centre. The trial was initially announced on February 23rd 2021, with the most recent update having been posted October 27th 2022."

Answered by AI

Could you elucidate any previous experiments done with Nitric Oxide-Releasing Solution?

"Currently, 21 trials are actively researching the benefits of Nitric Oxide-Releasing Solution with 8 in Phase 3. Anchorage, Alaska is home to most studies; however 97 other sites across the globe have performed experiments on this subject."

Answered by AI

What is the primary purpose of this medical study?

"This clinical trial, which is slated to be completed within 29 days, aims to quantify the amount of methemoglobin present during NORS treatment in people with DFU. As secondary objectives, researchers are looking into how effective NORS is compared to placebo when it comes reducing bacterial loads and wound-related infections among participants; they will measure this by gauging mean changes in percentage of microbial species as well as comparing proportions of patients who report a resolution in their symptoms."

Answered by AI
~10 spots leftby Apr 2025