Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers
Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00475202
Collaborator
(none)
1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Prospective
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center | Zerifin | Israel | 70300 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00475202
Other Study ID Numbers:
- 6106
First Posted:
May 21, 2007
Last Update Posted:
May 21, 2007
Last Verified:
May 1, 2007