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Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

NCT ID: NCT00475202

Last Updated: 2007-05-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Foot Ulcers Hyperbaric Therapy Angiogenesis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Albert Rabinovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Efrati Shai, MD

Role: STUDY_CHAIR

Assaf-Harofeh Medical Center

Locations

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Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Albert Rabinovitz, MD

Role: CONTACT

[email protected]
+972-546-396503

Facility Contacts

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Albert Rabinovitz, MD

Role: primary

[email protected]
+972-546-39503

Other Identifiers

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6106

Identifier Type: -

Identifier Source: org_study_id