View Clinical Trial (Medical Research Study)
Impaired Wound Healing in Diabetic Foot Ulceration
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02215 |
| Conditions: |
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Diabetes Mellitus - Healthy Volunteers |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT00739323 |
| Primary Contact: |
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Principal Investigator
Aristidis Veves, DSc
Beth Israel Deaconess Medical Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02215
United States
Julie Guest, B.S.
Phone: 617-632-8420
Email: jguest@bidmc.harvard.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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