Clinical trial NCT00387101: Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Diabetes Mellitus
Debridement
Dermal-LSR
Standard of Care
Lead sponsor: ApoPharma
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
state: Arizona
city: Mather
country: United States
facility: Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
state: California
city: San Diego
country: United States
facility: San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
state: California
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Des Plaines
country: United States
facility: Weil Foot and Ankle Institute
state: Illinois
city: Hines
country: United States
facility: Hines VA Hospital
state: Illinois
city: Niles
country: United States
facility: National Center for Lower Limb Preservation
state: Illinois
city: Boston
country: United States
facility: Foot Care Vascular and Endovascular Specialists of Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
state: Massachusetts
city: New Hyde Park
country: United States
facility: North Shore Diabetic and Endocrine Associates
state: New York
city: Cleveland
country: United States
facility: The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
state: Ohio
city: Reading
country: United States
facility: Center for Advanced Wound Care
state: Pennsylvania
Study officials:
affiliation: Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143
name: Jason R Hanft, DPM, FAC FAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118
name: Hau Pham, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141
name: Rodney Stuck, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Lower Limb Preservation, 8816 Dempster Street, Niles, Il 60714
name: Vickie Driver, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore Diabetic and Endocrine Associates, 3003 New Hyde Park Road Suite 201, New Hyde Park, NY, 11042
name: Zevi Isseroff, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Weil Foot and Ankle Institute, 1455 Golf Rd., Suite 110, Golf-River Professional Building, Des Plaines, IL 60016
name: Lowell Weil, Jr., DPM, MBA, FAC FAS
role: PRINCIPAL_INVESTIGATOR
affiliation: SPSK nr 2 im. H. Święcickiego AM Oddział Kliniczny Chirurgii Ogólnej Gastroenterologicznej i Endokrynologicznej ul. Przybyszewskiego 49
name: Michal Drews
role: PRINCIPAL_INVESTIGATOR
affiliation: Centrum Medyczno-Diagnostyczne Sp. z o.o. ul. Piłsudskiego 49 08-110 Siedlce Poland
name: Henryk Komon
role: PRINCIPAL_INVESTIGATOR
affiliation: SPWSZ w Szczecinie Klinika Endokrynologii, NadciśnieniaTętniczego i Chorób Przemiany Materii PAM ul. Arkońska 4 71-455 Szczecin
name: Krystyna Pilarska
role: PRINCIPAL_INVESTIGATOR
affiliation: NZOZ Centrum Opieki Diabetologiczno-Endokrynologicznej ul. Karola Miarki 6 50-306 Wrocław Poland
name: Malgorzata Wilczynska
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Advanced Wound Care 640 Walnut St., Suite 302 Reading, PA 19601
name: Joseph Cavorsi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans Affairs Northern Health Care System
name: Roslyn R Isseroff, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40, Cleveland, OH 44195,
name: Georgeanne Botek, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road, Boston, MA 02215
name: Adam Landsman, DPM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112), Tucson, AZ 85723
name: Jodi Walters, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego Research Center 4452 Park Boulevard Suite 210, San Diego, CA 92116
name: Martin Taubman, DPM
role: PRINCIPAL_INVESTIGATOR
References: