Status:
TERMINATED
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
Lead Sponsor:
ApoPharma
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-84 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00387101
Start Date
February 1 2006
End Date
April 1 2008
Last Update
May 2 2008
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon, Arizona, United States, 85723
2
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
Mather, California, United States, 95655
3
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
San Diego, California, United States, 92116
4
Doctors Research Network
South Miami, Florida, United States, 33143