- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00475202
Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Zerifin, Israel, 70300
- Rekruttering
- Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center
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Kontakt:
- Albert Rabinovitz, MD
- Telefonnummer: +972-546-39503
- E-mail: alik.r75@mail.ru
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Albert Rabinovitz, MD, Assaf-Harofeh Medical Center
- Studiestol: Efrati Shai, MD, Assaf-Harofeh Medical Center
Datoer for undersøgelser
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6106
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Kliniske forsøg med Diabetiske fodsår
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