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Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis

Primary Purpose

Wounds

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VAC® Therapy System
Sponsored by
3M
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds focused on measuring Angiogenesis, Post surgical dehisced wounds of the lower extremity

Eligibility Criteria

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

Inclusion Criteria: Patient is male or female and > 18 years old. Patient or patient's legal authorized representative is willing to sign informed consent. Patient has a post surgical dehisced wound of the lower extremity for longer than two weeks and less than one month. Patient has transcutaneous oximetry (TcPO2) evaluation that demonstrated tissue hypoxia in the periwound region, as indicated by a reading of 10-40 mmHg within the prior two weeks. Ankle Brachial Index > 0.7 within the prior two weeks. Patient is not pregnant (pregnancy test is negative) and non-lactating at Visit 1. Patient does not plan on becoming pregnant during the course of the study. Patient is willing to use effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least one year prior to enrollment in study. Exclusion Criteria: Diagnosed and untreated wound infection. Poor nutrition status as evidenced by pre-albumin < 12mg/dl within the past 30 days or extracellular mass < 95%. Presence of sickle cell disease. Presence of connective tissue disease (e.g. history of or active lupus). Hemoglobin A1c (HbA1c) levels greater than 9% thirty days prior to screening visit (if patient is confirmed diabetic). Treatment with an investigational therapy within the previous 30 days. Lower extremity wound (under consideration for study) with malignancy. Lower extremity wound (under consideration for study) with untreatable cellulitis. Presence of untreated osteomyelitis. Presence of any systemic hematologic disorder or condition that would impede healing. History of radiation to the wound area. History of drugs that may delay wound healing. History of thermal injury to the wound area. Prior VAC® therapy to the wound within 30 days of enrollment. Current or prior treatment with hyperbaric oxygen therapy (HBO) or warm-up therapy to the same wound. Recent diagnosis of cancer or active management of cancer within the last year. Treatment with skin or dermal substitutes or dressings with living cells capable of producing growth factors within the previous 30 days. End stage renal disease. History of alcohol or drug abuse that may impact protocol compliance or delay wound healing. Known hypersensitivity to hydrogel or any disposable component of the VAC® Therapy System. Necrotic tissue with eschar present which cannot be debrided. Any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28

    Secondary Outcome Measures

    Increased angiogenesis of the lower extremity wound will be quantified using the MicroScan™ (video microscope) at Day 0, Day 3, Day 7, Day 21, Day 28, Day 42, and at follow up visit.

    Full Information

    First Posted
    October 5, 2005
    Last Updated
    July 29, 2022
    Sponsor
    3M
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00234559
    Brief Title
    Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
    Official Title
    A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study terminated due to no subject enrollment.
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    3M

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine: If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wounds
    Keywords
    Angiogenesis, Post surgical dehisced wounds of the lower extremity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    VAC® Therapy System
    Primary Outcome Measure Information:
    Title
    Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28
    Secondary Outcome Measure Information:
    Title
    Increased angiogenesis of the lower extremity wound will be quantified using the MicroScan™ (video microscope) at Day 0, Day 3, Day 7, Day 21, Day 28, Day 42, and at follow up visit.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is male or female and > 18 years old. Patient or patient's legal authorized representative is willing to sign informed consent. Patient has a post surgical dehisced wound of the lower extremity for longer than two weeks and less than one month. Patient has transcutaneous oximetry (TcPO2) evaluation that demonstrated tissue hypoxia in the periwound region, as indicated by a reading of 10-40 mmHg within the prior two weeks. Ankle Brachial Index > 0.7 within the prior two weeks. Patient is not pregnant (pregnancy test is negative) and non-lactating at Visit 1. Patient does not plan on becoming pregnant during the course of the study. Patient is willing to use effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least one year prior to enrollment in study. Exclusion Criteria: Diagnosed and untreated wound infection. Poor nutrition status as evidenced by pre-albumin < 12mg/dl within the past 30 days or extracellular mass < 95%. Presence of sickle cell disease. Presence of connective tissue disease (e.g. history of or active lupus). Hemoglobin A1c (HbA1c) levels greater than 9% thirty days prior to screening visit (if patient is confirmed diabetic). Treatment with an investigational therapy within the previous 30 days. Lower extremity wound (under consideration for study) with malignancy. Lower extremity wound (under consideration for study) with untreatable cellulitis. Presence of untreated osteomyelitis. Presence of any systemic hematologic disorder or condition that would impede healing. History of radiation to the wound area. History of drugs that may delay wound healing. History of thermal injury to the wound area. Prior VAC® therapy to the wound within 30 days of enrollment. Current or prior treatment with hyperbaric oxygen therapy (HBO) or warm-up therapy to the same wound. Recent diagnosis of cancer or active management of cancer within the last year. Treatment with skin or dermal substitutes or dressings with living cells capable of producing growth factors within the previous 30 days. End stage renal disease. History of alcohol or drug abuse that may impact protocol compliance or delay wound healing. Known hypersensitivity to hydrogel or any disposable component of the VAC® Therapy System. Necrotic tissue with eschar present which cannot be debrided. Any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey A Niezgoda, M.D.
    Organizational Affiliation
    St. Luke's Medical Center of Aurora Health Care
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis

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