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Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

NCT00953186 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2011-11-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

hyperbaric air

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

DEVICE

HBOT

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

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Region Skåne Sweden

    collaborator OTHER_GOV

  • Gorthons Foundation Helsingborg Sweden

    collaborator UNKNOWN

  • Mrs. Thelma Zoegas Foundation

    lead OTHER

Principal Investigators

  • Magnus Löndahl, MD · Inst Clinical Sciences in Lund, Lund University, Sweden

  • Per L Katzman, ass prof, MD · Inst Clinical Sciences in Lund, Lund University, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953186 on ClinicalTrials.gov