Diabetic Foot UlcerPhase 3NCT00387101
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
A Phase 3 study testing Dermal - Living Skin Replacement (Dermal - LSR) in people with Diabetic Foot Ulcer, run by ApoPharma at 12 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dermal - Living Skin Replacement (Dermal - LSR)
- Type of treatment
- Medical device
- How many people
- 288 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2006to Apr 2008
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed a written informed consent prior to the first study intervention
- Is at least 18 and <85 years of age
- Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks
- Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
- Has a maximum fasting blood glucose level of 13.8 mmol/L
- An ankle-brachial systolic pressure index between 0.7 and 1.3
- If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study
- Able and willing to attend the scheduled visits and comply with study procedures.
Who cannot join
- Known or suspected disease of the immune system
- Active or untreated malignancy or active, uncontrolled connective tissue disease
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
- Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
- Active febrile illness
Show all 16Show fewer
- AST, ALT, ALP >3x the normal upper limit
- Serum Creatinine >2x the normal upper limit
- Osteomyelitis
- Active Charcot
- Use of any topical treatments other than SOC (standard of care)at the time of enrollment
- Enrollment in any investigational clinical trial within 30 days of the screening visit
- Known or suspected hypersensitivity to any study product components
- Recent or current history of alcohol or drug abuse
- Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
- All site personnel directly affiliated with this study and their immediate families
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
Boston, Massachusetts, 02118
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
Boston, Massachusetts, 02215
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
Cleveland, Ohio, 44195
Weil Foot and Ankle Institute
Des Plaines, Illinois, 60016
Hines VA Hospital
Hines, Illinois, 60141
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
Mather, California, 95655
North Shore Diabetic and Endocrine Associates
New Hyde Park, New York, 11042
National Center for Lower Limb Preservation
Niles, Illinois, 60714
Center for Advanced Wound Care
Reading, Pennsylvania, 19601
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
San Diego, California, 92116
Doctors Research Network
South Miami, Florida, 33143
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon, Arizona, 85723
About this study
Official title: Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
Read the detailed description
The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dermal - Living Skin Replacement (Dermal - LSR)
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Dermal-LSR, Standard of Care
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal - Living Skin Replacement (Dermal - LSR)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionApr 2008
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ApoPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jason R Hanft, DPM, FAC FAS, Principal investigator, Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143Hau Pham, DPM, Principal investigator, Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118Rodney Stuck, DPM, Principal investigator, Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141Vickie Driver, DPM, Principal investigator, National Center for Lower Limb Preservation, 8816 Dempster Street, Niles, Il 60714Zevi Isseroff, DPM, Principal investigator, North Shore Diabetic and Endocrine Associates, 3003 New Hyde Park Road Suite 201, New Hyde Park, NY, 11042Lowell Weil, Jr., DPM, MBA, FAC FAS, Principal investigator, Weil Foot and Ankle Institute, 1455 Golf Rd., Suite 110, Golf-River Professional Building, Des Plaines, IL 60016Michal Drews, Principal investigator, SPSK nr 2 im. H. Święcickiego AM Oddział Kliniczny Chirurgii Ogólnej Gastroenterologicznej i Endokrynologicznej ul. Przybyszewskiego 49Henryk Komon, Principal investigator, Centrum Medyczno-Diagnostyczne Sp. z o.o. ul. Piłsudskiego 49 08-110 Siedlce Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387101
- Sponsor's protocol ID
- RS03-2004
- Status last verified
- Apr 2008
- First submitted
- 10 Oct 2006
- Last updated
- 2 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00387101
- Acronym / sponsor ID
- RS03-2004
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Dermal-LSR, Standard of Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- ApoPharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Oct 2006 (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 purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
Detailed description
The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has signed a written informed consent prior to the first study intervention
- Is at least 18 and <85 years of age
- Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks
- Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
- Has a maximum fasting blood glucose level of 13.8 mmol/L
Key exclusion criteria (16 listed)
- Known or suspected disease of the immune system
- Active or untreated malignancy or active, uncontrolled connective tissue disease
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
- Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
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 |
|---|---|---|
| Dermal - Living Skin Replacement (Dermal - LSR) | Device | – |
Primary outcome
To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2008.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
Jason R Hanft, DPM, FAC FAS principal investigator
Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143
Hau Pham, DPM principal investigator
Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118
Rodney Stuck, DPM principal investigator
Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dermal - Living Skin Replacement (Dermal - LSR) in people with Diabetic Foot Ulcer, run by ApoPharma at 12 sites in United States.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 2 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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. 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 was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
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?
To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.. 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 May 2008.