Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Diabetic Foot Ulcers; Angiogenesis; Hyperbaric Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT00475202

6106

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.