Foot Ulcer, DiabeticPhase 3NCT00711217
Evaluation of a Medical Food for Chronic Wounds
A Phase 3 study testing Medical Food and Drink mix calorically similar to experimental product in people with Foot Ulcer, Diabetic, run by Abbott Nutrition at 51 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Medical Food and Drink mix calorically similar to experimental product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 51 sitesin 4 countries
- Study dates
- Jun 2008to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-pregnant
- diabetic
- neuropathic foot ulcer
- ABI> 0.7
Who cannot join
- uncontrolled DM
- collagen vascular disease or autoimmune disease
- wound infection; recent therapies with steroids
- growth factor or bioengineered tissue
- radiation therapy
- treatment with antibiotics within 1 week, Charcot's arthropathy of the foot
Show all 14Show fewer
- active malignancy
- renal function impairment
- liver failure
- planned surgery
- myocardial infarction within 3 months
- malnutrition
- substance abuse
- taking conflicting oral nutritional supplements
Trial locations and contacts
51 sites in 4 countries.
51 sites in 4 countries
United States46 sites
Akron General Medical Center, The Wound Care Center
Akron, Ohio, 44307
Blair Medical Associates, Inc.
Altoona, Pennsylvania, 16602
University of Alabama
Birmingham, Alabama, 35294-3360
Foot Care, Endovascular and Vascular Services Boston University School of Medicine
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center, Harvard University
Boston, Massachusetts, 02215
Foot and Ankle Specialist
Brawley, California, 92227
Carlisle Regional Medical Center, Advanced Wound Healing Center
Carlisle, Pennsylvania, 17015
Center for Clinical Research, Inc
Castro Valley, California, 94546
St. Vincent Charity Hospital, Wound Care Center
Cleveland, Ohio, 44115
Limb Salvage Centre
Dallas, Texas, 75231
Diabetic Foot and Wound Center
Denver, Colorado, 80220
Amputation Prevention Center Broadlawns Medical Center
Des Moines, Iowa, 50314
The Wound Institute and Research Center
Dunmore, Pennsylvania, 18512
Aiyan Diabetes Center
Evans, Georgia, 30809
Central Coast Foot and Ankle
Freedom, California, 95019
Garrett Noguchi, DPM, P.A.
Honolulu, Hawaii, 96817
Armstrong County Wound Healing Center
Kittanning, Pennsylvania, 16201
Advance Foot & Ankle Center
Las Vegas, Nevada, 89119
Foot and Ankle Clinic
Los Angeles, California, 90010
Complete Family Foot Care
McAllen, Texas, 78501
Doctor's Research Network
Miami, Florida, 33143
Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
North Chicago, Illinois, 60064
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, 94609
Chesapeake Research Group
Pasadena, Maryland, 21122
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Gerard J. Furst, DPM, PLLC
Port Jefferson Station, New York, 11776
Health Concepts
Rapid City, South Dakota, 57702
VA Medical Center
Reno, Nevada, 89502
Robert Wunderlich, DPM, P.A.
San Antonio, Texas, 78212
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
Therapeutics Clinical Research
San Diego, California, 92123
Advanced Clinical Research
San Jose, California, 95116
Christus Schumpert Wound Care Center & Hyperbaric Center
Shreveport, Louisiana, 71101
American Center for Clinical Trials
Southfield, Michigan, 48034
Foot Healthcare Associates
Southfield, Michigan, 48076
SCORE Physician Alliance
St. Petersburg, Florida, 33710
Pacific Wound Center
Stockton, California, 95204
South Florida Wound Care Group
Tamarac, Florida, 33321
Ankle and Foot Associates
Temple Terrace, Florida, 33617
ProMedica Health Systems
Toledo, Ohio, 43606
Precision Foot and Ankle Centers - Torrance
Torrance, California, 90505
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Trinity Mother Frances Hospitals and Clinics
Tyler, Texas, 75701
McHugh & Associates
Watertown, Connecticut, 06795
Spain2 sites
Clinica de Podologia, Ciudad Universitaria
Madrid, 28040
Centro de Diagnostico y Tratamiento Francisco Diaz
Madrid, 28806
United Kingdom2 sites
Diabetic Foot Clinic, King's College Hospital
London
Manchester Diabetes Centre
Manchester
About this study
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.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Medical Food, Drink mix calorically similar to experimental product
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical FoodOther
Also called AN0806A
twice daily
Drink mix calorically similar to experimental productOther
Also called AN0806B
twice daily
| Study group | Role | What they receive |
|---|---|---|
| #1 Medical food | Experimental | Not described Receives: Other: Medical Food |
| #2 Control | Placebo comparator | Not described Receives: Other: Drink mix calorically similar to experimental product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: 16 weeks
Secondary outcomes (4)
QOL
Measured: 16 weeks
Wound healing measures
Measured: 16 weeks
Incidence of complications
Measured: 16 weeks
Clinical outcome data
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Voss, PhD, RD, Study director, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711217
- Sponsor's protocol ID
- BK15
- Status last verified
- May 2011
- First submitted
- 23 Jun 2008
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Medical Food for Chronic Wounds
- ClinicalTrials.gov ID
- NCT00711217
- Acronym / sponsor ID
- BK15
- Conditions
- Foot Ulcer, Diabetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #1 Medical food | Experimental | Other: Medical Food |
| #2 Control | Placebo comparator | Other: Drink mix calorically similar to experimental product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-pregnant
- diabetic
- neuropathic foot ulcer
- ABI> 0.7
Key exclusion criteria (14 listed)
- uncontrolled DM
- collagen vascular disease or autoimmune disease
- wound infection; recent therapies with steroids
- growth factor or bioengineered tissue
- radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical FoodAlso: AN0806Atwice daily | Other | #1 Medical food |
| Drink mix calorically similar to experimental productAlso: AN0806Btwice daily | Other | #2 Control |
Primary outcome
Wound healing
Time frame: 16 weeks
4 secondary outcomes
QOL
Time frame: 16 weeks
Wound healing measures
Time frame: 16 weeks
Incidence of complications
Time frame: 16 weeks
Clinical outcome data
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Voss, PhD, RD study director
Abbott Nutrition
51 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medical Food and Drink mix calorically similar to experimental product in people with Foot Ulcer, Diabetic, run by Abbott Nutrition at 51 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Spain, United Kingdom, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.