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

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ClinicalTrials.gov Identifier: NCT00953186
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : November 8, 2011
Sponsor:
Collaborators:
Lund University
Region Skåne Sweden
Gorthons Foundation Helsingborg Sweden
Information provided by:
Mrs. Thelma Zoegas Foundation

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.

Condition or disease Intervention/treatment Phase
Diabetes Foot Ulcer Healing Device: hyperbaric air Device: HBOT Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers
Study Start Date : June 2002
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Ulcer healing [ Time Frame: 3, 6, 9, 12, 18, 24 months ]

Secondary Outcome Measures :
  1. Amputationrate [ Time Frame: 6, 12, 24 months ]
  2. time to ulcer healing [ Time Frame: 24 months ]
  3. QoL [ Time Frame: 3, 6, 12, 18, 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: August 2009

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

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer