TerminatedNot Applicable

Hyperbaric Oxygen Therapy for Renal Regeneration in Diabetic Nephropathy

Stopped: difficulties in recruiting.

Israel7 participantsStarted 2015-09-01

Plain-language summary

Diabetes kidney disease is a leading cause for end stage renal disease in the western world. To date no treatment that can reverse renal damage exists. Chronic hypoxia is one of the major key insults affecting the diabetic kidney, and many of the new treatments under study focus on it's consequences, but no treatment can improve the hypoxia as both increased renal perfusion and decreased renal perfusion may be associated with it's worsening. Hyperbaric oxygen therapy (HBOT) can improve renal hypoxia by increasing partial pressure of dissolved (non-hemoglobin-bound) oxygen without affecting it's demand. HBOT also recruits tissue and peripheral progenitors and supplies the optimal environment crucial for their proliferation and for tissue repair. Hyperbaric oxygen treatment was known for years as an effective treatment for diabetic ulcers. Recent trials have shown great impact on brain lesions (in diabetic and non-diabetic patients) it is now the time to evaluate the effect of HBOT on the diabetic kidney.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The participants are patients of age 18 years or older, who suffered DKD, defined as eGFR\<60ml/min as estimated using MDRD formula, and albuminuria in the presence of diabetes. Diabetic retinopathy and without any alternative cause for their renal disease. Exclusion Criteria: * Exclusions criteria are chest pathology incompatible with HBOT, inner ear disease, claustrophobia. Smoking is not allowed during the study. Patients with uncontrolled diabetes HBA1C\>7.5, recent AKI (3M) recent cardiovascular or cerebrovascular event (6M) or inability to hold the breath for 20-30 seconds are also excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

glomerular filtration rate

Timeframe: within a month after treatment

proteinuria

Timeframe: within a month after treatment

Trial details

NCT IDNCT03376282

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-05-04

View on ClinicalTrials.gov More Chronic Renal Failure trials