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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| #1 Medical food | Experimental |
| |
| #2 Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Food | Other | twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| QOL | 16 weeks | |
| Wound healing measures | 16 weeks | |
| Incidence of complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Voss, PhD, RD | Abbott Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-3360 | United States | ||
| Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System |
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| Drink mix calorically similar to experimental product | Other | twice daily |
|
|
| 16 weeks |
| Clinical outcome data | 16 weeks |
| Tucson |
| Arizona |
| 85723 |
| United States |
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | United States |
| Foot and Ankle Specialist | Brawley | California | 92227 | United States |
| Center for Clinical Research, Inc | Castro Valley | California | 94546 | United States |
| Central Coast Foot and Ankle | Freedom | California | 95019 | United States |
| Foot and Ankle Clinic | Los Angeles | California | 90010 | United States |
| California School of Podiatric Medicine at Samuel Merritt University | Oakland | California | 94609 | United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Advanced Clinical Research | San Jose | California | 95116 | United States |
| Pacific Wound Center | Stockton | California | 95204 | United States |
| Precision Foot and Ankle Centers - Torrance | Torrance | California | 90505 | United States |
| Diabetic Foot and Wound Center | Denver | Colorado | 80220 | United States |
| McHugh & Associates | Watertown | Connecticut | 06795 | United States |
| Doctor's Research Network | Miami | Florida | 33143 | United States |
| SCORE Physician Alliance | St. Petersburg | Florida | 33710 | United States |
| South Florida Wound Care Group | Tamarac | Florida | 33321 | United States |
| Ankle and Foot Associates | Temple Terrace | Florida | 33617 | United States |
| Aiyan Diabetes Center | Evans | Georgia | 30809 | United States |
| Garrett Noguchi, DPM, P.A. | Honolulu | Hawaii | 96817 | United States |
| Rosalind Franklin University, Center for Lower Extremity Ambulatory Research | North Chicago | Illinois | 60064 | United States |
| Amputation Prevention Center Broadlawns Medical Center | Des Moines | Iowa | 50314 | United States |
| Christus Schumpert Wound Care Center & Hyperbaric Center | Shreveport | Louisiana | 71101 | United States |
| Chesapeake Research Group | Pasadena | Maryland | 21122 | United States |
| Foot Care, Endovascular and Vascular Services Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center, Harvard University | Boston | Massachusetts | 02215 | United States |
| American Center for Clinical Trials | Southfield | Michigan | 48034 | United States |
| Foot Healthcare Associates | Southfield | Michigan | 48076 | United States |
| Advance Foot & Ankle Center | Las Vegas | Nevada | 89119 | United States |
| VA Medical Center | Reno | Nevada | 89502 | United States |
| Gerard J. Furst, DPM, PLLC | Port Jefferson Station | New York | 11776 | United States |
| Akron General Medical Center, The Wound Care Center | Akron | Ohio | 44307 | United States |
| St. Vincent Charity Hospital, Wound Care Center | Cleveland | Ohio | 44115 | United States |
| ProMedica Health Systems | Toledo | Ohio | 43606 | United States |
| Blair Medical Associates, Inc. | Altoona | Pennsylvania | 16602 | United States |
| Carlisle Regional Medical Center, Advanced Wound Healing Center | Carlisle | Pennsylvania | 17015 | United States |
| The Wound Institute and Research Center | Dunmore | Pennsylvania | 18512 | United States |
| Armstrong County Wound Healing Center | Kittanning | Pennsylvania | 16201 | United States |
| Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Limb Salvage Centre | Dallas | Texas | 75231 | United States |
| Complete Family Foot Care | McAllen | Texas | 78501 | United States |
| Robert Wunderlich, DPM, P.A. | San Antonio | Texas | 78212 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Endeavor Clinical Trials, PA | San Antonio | Texas | 78229 | United States |
| Trinity Mother Frances Hospitals and Clinics | Tyler | Texas | 75701 | United States |
| Clinica de Podologia, Ciudad Universitaria | Madrid | 28040 | Spain |
| Centro de Diagnostico y Tratamiento Francisco Diaz | Madrid | 28806 | Spain |
| Chang Gung Memorial Hospital | Taipei | Taiwan |
| Diabetic Foot Clinic, King's College Hospital | London | United Kingdom |
| Manchester Diabetes Centre | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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