Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

Phase 3

Terminated

• 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-12
• Primary Completion: 2007-09
• Status Verified: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2008-04-30
• Last Update Posted: 2008-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• 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 Criteria

• 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.

Trial Locations

Locations (12)

Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112); 🇺🇸 Tuscon, Arizona, United States

Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather; 🇺🇸 Mather, California, United States

San Diego Research Center 4452 Park Boulevard Suite 210, San Diego; 🇺🇸 San Diego, California, United States

Doctors Research Network; 🇺🇸 South Miami, Florida, United States

Weil Foot and Ankle Institute; 🇺🇸 Des Plaines, Illinois, United States

Hines VA Hospital; 🇺🇸 Hines, Illinois, United States

National Center for Lower Limb Preservation; 🇺🇸 Niles, Illinois, United States

Foot Care Vascular and Endovascular Specialists of Boston Medical Center; 🇺🇸 Boston, Massachusetts, 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

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