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Sponsored by: |
Abbott Nutrition |
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Information provided by: | Abbott Nutrition |
ClinicalTrials.gov Identifier: | NCT00711217 |
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
Condition | Intervention | Phase |
---|---|---|
Foot Ulcer, Diabetic |
Other: Medical Food Other: Drink mix calorically similar to experimental product |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of a Medical Food for Chronic Wounds |
Estimated Enrollment: | 248 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
#1 Medical food: Experimental |
Other: Medical Food
twice daily
|
#2 Control: Placebo Comparator |
Other: Drink mix calorically similar to experimental product
twice daily
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bobbie L Swearengin, RN | 614-624-7182 | Bobbie.Swearengin@abbott.com |
United States, Alabama | |
University of Alabama | Recruiting |
Birmingham, Alabama, United States, 35294-3360 | |
Principal Investigator: Andres Julian Munoz, MD | |
United States, Colorado | |
Diabetic Foot and Wound Center | Recruiting |
Denver, Colorado, United States, 80220 | |
Principal Investigator: Eric Jaakola, DPM | |
United States, Florida | |
Doctor's Research Network | Recruiting |
Miami, Florida, United States, 33143 | |
Principal Investigator: Jason Hanft, DPM | |
United States, Iowa | |
Amputation Prevention Center Broadlawns Medical Center | Recruiting |
Des Moines, Iowa, United States, 50314 | |
Principal Investigator: Lee C Rogers, DPM | |
United States, Massachusetts | |
Foot Care, Endovascular and Vascular Services Boston University School of Medicine | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Principal Investigator: Vickie Driver, DPM, FACFAS | |
United States, Nevada | |
VA Medical Center | Recruiting |
Reno, Nevada, United States, 89502 | |
Principal Investigator: Patricia May, MD | |
United States, New York | |
North Shore Podiatry Group | Recruiting |
Port Jefferson Station, New York, United States, 11776 | |
Principal Investigator: Gerald Furst, DPM | |
United States, Ohio | |
The Wound Care Center | Recruiting |
Akron, Ohio, United States, 44307 | |
Principal Investigator: Amy Tucker, MD | |
ProMedica Health Systems | Recruiting |
Toledo, Ohio, United States, 43606 | |
Principal Investigator: Matthew Wilkin, DPM | |
United States, Pennsylvania | |
Temple University School of Podiatric Medicine | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Principal Investigator: James McGuire, MD | |
United States, Texas | |
DCS, Trinity Mother Frances Hospitals and Clinics | Recruiting |
Tyler, Texas, United States, 75701 | |
Principal Investigator: Maxine Theriot |
Study Director: | Anne Voss, PhD, RD | Abbott Nutrition |
Responsible Party: | Abbott Nutrition ( Bobbie Swearengin, Director Clinical Research Operations ) |
Study ID Numbers: | BK15 |
Study First Received: | June 23, 2008 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00711217 History of Changes |
Health Authority: | United States: Institutional Review Board |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Foot Diseases Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Foot Ulcer Skin Diseases Diabetic Neuropathies Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Cardiovascular Diseases Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |