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

This study has been withdrawn prior to enrollment.
(Study terminated due to no subject enrollment.)
Sponsor:
Information provided by:
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT00234559
First received: October 5, 2005
Last updated: August 19, 2013
Last verified: August 2013

October 5, 2005
August 19, 2013
September 2005
August 2007   (final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT00234559 on ClinicalTrials.gov Archive Site
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.
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 follow up visit.
Not Provided
Not Provided
 
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis

The purpose of this study is to determine:

  1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.
  2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Wounds
Device: VAC® Therapy System
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2007
August 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00234559
VACP2005-001
Not Provided
Not Provided
KCI USA, Inc.
Not Provided
Principal Investigator: Jeffrey A Niezgoda, M.D. St. Luke's Medical Center of Aurora Health Care
KCI USA, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP