Impaired Wound Healing in Diabetic Foot Ulceration (EPC)
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Impaired Wound Healing in Diabetic Foot Ulceration |
| Estimated Enrollment: | 110 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
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: | 21 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.
- 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
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Julie Guest, B.S. 617-632-8420 jguest@bidmc.harvard.edu | |
| Principal Investigator: Aristidis Veves | |
| Principal Investigator: | Aristidis Veves, DSc | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Aristidis Veves, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00739323 History of Changes |
| Other Study ID Numbers: | DK76937, R01DK076937, 1R01DK076937 |
| Study First Received: | August 19, 2008 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Ulcer Foot Ulcer Diabetic Foot Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Foot Diseases |
Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 21, 2013