Impaired Wound Healing in Diabetic Foot Ulceration (EPC)
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ClinicalTrials.gov Identifier: NCT00739323
Recruitment Status :
First Posted : August 21, 2008
Last Update Posted : March 1, 2017
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Aristidis Veves, Beth Israel Deaconess Medical Center
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 healing. The study also examines the association of a specific type of cell with the rate of wound healing.
Condition or disease
Diabetes MellitusHealthy Volunteers
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 skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).
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Ages Eligible for Study:
21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area and surrounding locations.
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
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)