Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00475202
• Other study ID #: 6106
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2007
• Last updated: May 17, 2007

Study information

• Verified date: May 2007
• Source: Assaf-Harofeh Medical Center
• Contact: Albert Rabinovitz, MD
• Phone: +972-546-396503
• Email: alik.r75[@]mail.ru
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Angiogenesis
• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Hyperbaric Therapy

Locations

Country	Name	City	State
Israel	Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,