Trial record 1 of 1 for: HODFU

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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

Study Description

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 Design

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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

MedlinePlus related topics: Foot Health Oxygen Therapy

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Ulcer healing [ Time Frame: 3, 6, 9, 12, 18, 24 months ]

Secondary Outcome Measures :

Amputationrate [ Time Frame: 6, 12, 24 months ]
time to ulcer healing [ Time Frame: 24 months ]
QoL [ Time Frame: 3, 6, 12, 18, 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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.

Contacts and Locations

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

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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

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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:

Löndahl 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.

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

Löndahl 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.

Löndahl 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.

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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:

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Foot Ulcer Ulcer Pathologic Processes Foot Diseases	Skin Diseases Leg Ulcer Skin Ulcer

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