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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00739323 |
Purpose
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 |
|
Diabetes Mellitus Healthy Volunteers |
| MedlinePlus related topics: | Diabetes Diabetic Foot Foot Health |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Impaired Wound Healing in Diabetic Foot Ulceration |
| Estimated Enrollment: | 110 |
| Study Start Date: | December 2006 |
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).
Eligibility
| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area and surrounding locations.
Inclusion Criteria:
Current diagnosis of Type I or Type II Diabetes Mellitus.
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 transplantion, 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.
Contacts and Locations| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02215 | |||||
| Contact: Rachel Cloutier 617-632-8429 rclouti1@bidmc.harvard.edu | |||||
| Principal Investigator: Aristidis Veves | |||||
| Principal Investigator: | Aristidis Veves, DSc | Beth Israel Deaconess Medical Center |
More Information
| Responsible Party: | Beth Israel Deaconess Medical Center ( Aristidis Veves ) |
| Study ID Numbers: | DK76937, 1R01DK076937 |
| First Received: | August 19, 2008 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00739323 |
| Health Authority: | United States: Institutional Review Board |
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