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Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

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ClinicalTrials.gov Identifier: NCT00475202
Recruitment Status : Unknown
Verified May 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : May 21, 2007
Last Update Posted : May 21, 2007
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all non-traumatic amputations performed in the United States. The cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics, debridement, and revascularization in the therapy of chronic, nonhealing wounds associated with diabetes or non-diabetic vascular insufficiency.

The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients with foot ulcers.


Condition or disease
Diabetic Foot Ulcers Hyperbaric Therapy Angiogenesis

Study Type : Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years or older, with type II diabetes suffering from foot ulcers admitted to the Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center (Israel)

Exclusion Criteria:

  • Patients having chest pathology incompatible with pressure changes, inner ear disease, or suffering from claustrophobia, will be excluded from the study. Patients with significant macrovascular disease, defined as obstruction of more than 50% in the femoral or the popliteal arteries, will also be excluded from the study.

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): NCT00475202


Contacts
Contact: Albert Rabinovitz, MD +972-546-396503 alik.r75@mail.ru

Locations
Israel
Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Albert Rabinovitz, MD    +972-546-39503    alik.r75@mail.ru   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Albert Rabinovitz, MD Assaf-Harofeh Medical Center
Study Chair: Efrati Shai, MD Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier: NCT00475202     History of Changes
Other Study ID Numbers: 6106
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases