Healthy Volunteers Clinical Trial
— EPCOfficial title:
Impaired Wound Healing in Diabetic Foot Ulceration
Verified date | February 2017 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 137 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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