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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00387101
• Other study ID #: RS03-2004
• Status: Terminated
• Phase: Phase 3
• First received: October 10, 2006
• Last updated: April 30, 2008
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: ApoPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyCanada: Health Canada
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 288
• Est. completion date: April 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Dermal - Living Skin Replacement (Dermal - LSR)

Locations

Country	Name	City	State
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	The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40	Cleveland	Ohio
United States	Weil Foot and Ankle Institute	Des Plaines	Illinois
United States	Hines VA Hospital	Hines	Illinois
United States	Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather	Mather	California
United States	North Shore Diabetic and Endocrine Associates	New Hyde Park	New York
United States	National Center for Lower Limb Preservation	Niles	Illinois
United States	Center for Advanced Wound Care	Reading	Pennsylvania
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	Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ApoPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.