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This study has been withdrawn prior to enrollment.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
  Purpose

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.

Condition Intervention
Wounds
Device: VAC® Therapy System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis

Further study details as provided by KCI USA, Inc.:

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.

Enrollment: 0
Study Start Date: September 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234559

Sponsors and Collaborators
KCI USA, Inc.
Investigators
Principal Investigator: Jeffrey A Niezgoda, M.D. St. Luke's Medical Center of Aurora Health Care
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234559     History of Changes
Other Study ID Numbers: VACP2005-001
Study First Received: October 5, 2005
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by KCI USA, Inc.:
Angiogenesis
Post surgical dehisced wounds of the lower extremity

ClinicalTrials.gov processed this record on October 19, 2014