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

Primary Purpose

Diabetic Foot Ulcer

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Dermal - Living Skin Replacement (Dermal - LSR)

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Dermal-LSR, Standard of Care

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
Doctors Research Network
Weil Foot and Ankle Institute
Hines VA Hospital
National Center for Lower Limb Preservation
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
North Shore Diabetic and Endocrine Associates
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
Center for Advanced Wound Care

Outcomes

Primary Outcome Measures

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

Full Information

NCT ID

NCT00387101

First Posted

October 10, 2006

Last Updated

April 30, 2008

Sponsor

ApoPharma

1. Study Identification

Unique Protocol Identification Number

NCT00387101

Brief Title

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

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment rate

Study Start Date

February 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ApoPharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Dermal-LSR, Standard of Care

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Dermal - Living Skin Replacement (Dermal - LSR)

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

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

Overall Study Officials: