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Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers (HODFU)

This study has been completed.
Sponsor:
Collaborators:
Lund University
Region Skåne Sweden
Gorthons Foundation Helsingborg Sweden
Information provided by:
Mrs. Thelma Zoegas Foundation
ClinicalTrials.gov Identifier:
NCT00953186
First received: July 28, 2009
Last updated: November 7, 2011
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Foot Ulcer
Healing
 Device: hyperbaric air
Device: HBOT
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mrs. Thelma Zoegas Foundation:

Primary Outcome Measures:
  • Ulcer healing [ Time Frame: 3, 6, 9, 12, 18, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amputationrate [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • time to ulcer healing [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • QoL [ Time Frame: 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: June 2002
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
 Device: HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Placebo Comparator: Placebo
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
 Device: hyperbaric air
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953186

Locations
Sweden
Dept Anesthesiology, Helsingborg Hospital
Helsingborg, Sweden, S 221 57
Sponsors and Collaborators
Mrs. Thelma Zoegas Foundation
Lund University
Region Skåne Sweden
Gorthons Foundation Helsingborg Sweden
Investigators
Principal Investigator: Magnus Löndahl, MD Inst Clinical Sciences in Lund, Lund University, Sweden
Study Chair: Per L Katzman, ass prof, MD Inst Clinical Sciences in Lund, Lund University, Sweden
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Magnus Löndahl, MD, Senior consultant, Dept Endocrinology, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00953186     History of Changes
Other Study ID Numbers: Z012094
Study First Received: July 28, 2009
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration
Sweden: Institutional Review Board

Keywords provided by Mrs. Thelma Zoegas Foundation:
Diabetes
Foot ulcer
Neuropathy
Ischemia

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer

ClinicalTrials.gov processed this record on May 23, 2013