Status:

COMPLETED

Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

Lead Sponsor:

Mrs. Thelma Zoegas Foundation

Collaborating Sponsors:

Lund University

Region Skåne Sweden

Conditions:

Diabetes

Foot Ulcer

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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.

Eligibility Criteria

Inclusion

  • diabetes mellitus,
  • foot ulcer with duration \> 3 months,
  • treatment at Diabetes foot clinic for \> 2 months,
  • vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion

  • severe obstructive pulmonary disease,
  • malignancy and untreated thyrotoxicosis),
  • current drug or alcohol misuse,
  • vascular surgery in the lower limbs within the last two months,
  • participation in another study or suspected poor compliance.

Key Trial Info

Start Date :

June 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2009

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT00953186

Start Date

June 1 2002

End Date

June 1 2009

Last Update

November 8 2011

Active Locations (1)

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1

Dept Anesthesiology, Helsingborg Hospital

Helsingborg, Sweden, S 221 57