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Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00475202
First received: May 16, 2007
Last updated: May 17, 2007
Last verified: May 2007
History of Changes
  Purpose

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
Diabetic Foot Ulcers
Hyperbaric Therapy
Angiogenesis

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00475202     History of Changes
Other Study ID Numbers: 6106
Study First Received: May 16, 2007
Last Updated: May 17, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on June 18, 2013