Status:
COMPLETED
Impaired Wound Healing in Diabetic Foot Ulceration
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus
Healthy Volunteers
Eligibility:
MALE
21-80 years
Brief Summary
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound he...
Detailed Description
An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the...
Eligibility Criteria
Inclusion
- Current diagnosis of Type I or Type II Diabetes Mellitus.
- Ulcer present for minimum 4 weeks
- Have adequate circulation to the foot
- Can return for follow-up visits
- Be able to read and sign the Informed Consent form before enrollment
Exclusion
- Active Charcot's foot ulcer on the foot to be studied
- Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
- Alcohol or drug abuse problems
- Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
- Pregnancy
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00739323
Start Date
December 1 2006
End Date
September 1 2012
Last Update
March 1 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215