An interventional study of N-acetylcysteine in Diabetic Foot Ulcers, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-17.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. However, some patients have insufficient increase or even paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was to investigate the pathophysiology responsible for the different consequences of HBOT and to evaluate the effect of N-acetylcysteine (NAC) on these changes.
Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete HBOT protocol.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 845 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The aim of the present study was to investigate whether changes in oxidative stress and NO bioavailability are responsible for the different effects of HBOT on tissue oxygenation in diabetic patients suffering from foot ulcers.
This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Acetylcysteine
Assaf-Harofeh Medical Center →