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A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX

Primary Purpose

Foot Ulcer, Diabetic Foot, Skin Ulcer

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Becaplermin
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer focused on measuring Regranex, Foot ulcers, Diabetes, Diabetes mellitus, Diabetic foot

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12% Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters No exposed bone at the ulcer site No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Adequate arterial circulation to the foot New ulcers must be meet the following criteria: full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Recurrent ulcers must meet the following criteria: stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test Exclusion Criteria: Hypersensitivity to REGRANEX® Gel or one of its components Presence of more than two full-thickness diabetic ulcers on either lower extremity presence of an active systemic or local cancer or tumor of any kind Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation Radiation therapy that included the distal lower extremity, at any time in patient's life Charcot deformity (rocker bottom foot)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to complete ulcer healing.

    Secondary Outcome Measures

    Incidence of complete ulcer healing and reduction in total ulcer area at end of study. Incidence of adverse events throughout study.

    Full Information

    First Posted
    May 2, 2002
    Last Updated
    June 6, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00034788
    Brief Title
    A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX
    Official Title
    A Multicenter Clinical Evaluation of the Efficacy and Safety of REGRANEX Gel in the Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Slow recruitment; Study did not address safety concern raised by European Medicines Agency
    Study Start Date
    December 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
    Detailed Description
    This study has an initial open-label treatment period of up to 20 weeks with REGRANEX® gel for ulcers of the ankle or foot related to diabetes mellitus. Gel is applied once a day in a thin layer to cover the entire surface of the ulcer; then a non-adherent dressing and gauze are used to cover the gel. If all ulcers are healed during this open-label period, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If one or more ulcers are not healed during the 20 weeks, of if an ulcer recurs or a new ulcer is observed during up to 24 weeks of observation, then the patient enters Double-blind Phase #1 during which neither the patient nor the physician knows whether the study drug or placebo is being applied to the ulcer. This Phase #1 may continue for up to 52 weeks. If one or more ulcers are not healed during 52 weeks of treatment, the patient discontinues the study. If all ulcers are healed during this phase, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If an ulcer recurs or a new ulcer is observed during the observation period following Phase #1 treatment, then the patient enters Double-blind Phase #2 of the study for up to 20 weeks. If the ulcer is healed during Phase #2 treatment, the patient discontinues from the study at that time. If the ulcer remains unhealed after 20 weeks of Phase #2, the study is stopped. Efficacy assessments include the time to complete healing of the ulcer, the incidence of complete ulcer healing, and the reduction in total ulcer area at the end of the study. Safety assessments include the incidence of adverse events throughout the study, changes in clinical laboratory tests (hematology, chemistry, urinalysis), measurement of vital signs at specified intervals, and physical examinations at the start and end of the study. The study hypothesis is that the time to complete healing of diabetic foot ulcers with continued treatment using REGRANEX® is shorter than the time to healing with placebo and that the patients will well tolerate the medication. REGRANEX® gel (or placebo) applied to cover the entire surface of the ulcer, once a day for up to 52 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Foot Ulcer, Diabetic Foot, Skin Ulcer, Diabetic Neuropathies
    Keywords
    Regranex, Foot ulcers, Diabetes, Diabetes mellitus, Diabetic foot

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Becaplermin
    Primary Outcome Measure Information:
    Title
    Time to complete ulcer healing.
    Secondary Outcome Measure Information:
    Title
    Incidence of complete ulcer healing and reduction in total ulcer area at end of study. Incidence of adverse events throughout study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12% Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters No exposed bone at the ulcer site No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Adequate arterial circulation to the foot New ulcers must be meet the following criteria: full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Recurrent ulcers must meet the following criteria: stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test Exclusion Criteria: Hypersensitivity to REGRANEX® Gel or one of its components Presence of more than two full-thickness diabetic ulcers on either lower extremity presence of an active systemic or local cancer or tumor of any kind Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation Radiation therapy that included the distal lower extremity, at any time in patient's life Charcot deformity (rocker bottom foot)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=514&filename=CR003238_CSR.pdf
    Description
    Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo

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    A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX

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