Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers
NCT ID: NCT00953186
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
94 participants
INTERVENTIONAL
2002-06-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Placebo
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
hyperbaric air
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Interventions
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hyperbaric air
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Lund University
OTHER
Region Skåne Sweden
OTHER_GOV
Gorthons Foundation Helsingborg Sweden
UNKNOWN
Mrs. Thelma Zoegas Foundation
OTHER
Responsible Party
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Dept Endocrinology, Lund University Hospital
Principal Investigators
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Magnus Löndahl, MD
Role: PRINCIPAL_INVESTIGATOR
Inst Clinical Sciences in Lund, Lund University, Sweden
Per L Katzman, ass prof, MD
Role: STUDY_CHAIR
Inst Clinical Sciences in Lund, Lund University, Sweden
Locations
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Dept Anesthesiology, Helsingborg Hospital
Helsingborg, , Sweden
Countries
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References
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Londahl M, Katzman P, Nilsson A, Hammarlund C, Sellman A, Wykman A, Hugo-Persson M, Apelqvist J. A prospective study: hyperbaric oxygen therapy in diabetics with chronic foot ulcers. J Wound Care. 2006 Nov;15(10):457-9. doi: 10.12968/jowc.2006.15.10.26970.
Londahl M, Katzman P, Hammarlund C, Nilsson A, Landin-Olsson M. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2011 Jan;54(1):65-8. doi: 10.1007/s00125-010-1946-y. Epub 2010 Oct 19.
Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010 May;33(5):998-1003. doi: 10.2337/dc09-1754.
Other Identifiers
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Z012094
Identifier Type: -
Identifier Source: org_study_id