search
Back to results

Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bi-layered cell therapy (Apligraf)
Sponsored by
Organogenesis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot

Eligibility Criteria

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

Inclusion Criteria:

  • diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
  • ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
  • ulcer present for at least 2 weeks and measuring 1- 16 cm2
  • diminished sensesation on target extremity/foot
  • ulcer is not infected
  • Type 1 or 2 diabetes with adequate glycemic control
  • Adequate vascular supply to the target extremity

Exclusion Criteria:

  • Charcot foot
  • Non-neuropathic ulcers
  • Skin cancer within or adjacent to the target ulcer
  • Osteomyelitis or an infected ulcer
  • Clinically significant medical condition that would impair wound healing
  • Females who are pregnant
  • Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to complete wound healing (full epithelialization with no drainage)

    Secondary Outcome Measures

    Incidence of complete healing

    Full Information

    First Posted
    August 3, 2007
    Last Updated
    August 3, 2007
    Sponsor
    Organogenesis
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00512538
    Brief Title
    Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
    Official Title
    A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    Interruption of business relations between Study Sponsor and Device Manufacturer
    Study Start Date
    October 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Organogenesis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
    Detailed Description
    Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced. This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot
    Keywords
    Diabetic foot

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Bi-layered cell therapy (Apligraf)
    Primary Outcome Measure Information:
    Title
    Time to complete wound healing (full epithelialization with no drainage)
    Time Frame
    through 12 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of complete healing
    Time Frame
    at 12 weeks

    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: diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure ulcer present for at least 2 weeks and measuring 1- 16 cm2 diminished sensesation on target extremity/foot ulcer is not infected Type 1 or 2 diabetes with adequate glycemic control Adequate vascular supply to the target extremity Exclusion Criteria: Charcot foot Non-neuropathic ulcers Skin cancer within or adjacent to the target ulcer Osteomyelitis or an infected ulcer Clinically significant medical condition that would impair wound healing Females who are pregnant Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael E Edmonds, MD
    Organizational Affiliation
    Diabetic Foot Clinic, Kings College Hospital, London UK
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

    We'll reach out to this number within 24 hrs