CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 94 enrolled
Drug / intervention
hyperbaric air +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00953186
NCT00953186Phase 4Completed
CompareCT.gov

Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers

Mrs. Thelma Zoegas Foundation·interventional·Posted Aug 6, 2009·Updated Nov 8, 2011

In Brief

A Phase 4 clinical trial evaluating hyperbaric air and HBOT for Diabetes and 2 related conditions. Completed, enrolled 94 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Foot Ulcer, Healing
CountriesSweden
CollaboratorsLund University, Region Skåne Sweden, Gorthons Foundation Helsingborg Sweden

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2009
Enrollment StartJun 1, 2002
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 16.9 years ago

Interventions

hyperbaric airdevice

air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

HBOTdevice

100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber