Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcer
- Registration Number
- NCT00387101
- Lead Sponsor
- ApoPharma
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 288
- 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.
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
🇺🇸San Diego, California, United States
Center for Advanced Wound Care
🇺🇸Reading, Pennsylvania, United States
Doctors Research Network
🇺🇸South Miami, Florida, United States
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
🇺🇸Tuscon, Arizona, United States
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
🇺🇸Boston, Massachusetts, United States
North Shore Diabetic and Endocrine Associates
🇺🇸New Hyde Park, New York, United States
Hines VA Hospital
🇺🇸Hines, Illinois, United States
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
🇺🇸Cleveland, Ohio, United States
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
🇺🇸Boston, Massachusetts, United States
National Center for Lower Limb Preservation
🇺🇸Niles, Illinois, United States
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
🇺🇸Mather, California, United States
Weil Foot and Ankle Institute
🇺🇸Des Plaines, Illinois, United States