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

NCT00234559 | Withdrawn

• 1 other identifier: VACP2005-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine:

1. 1.If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.
2. 2.If VAC® therapy results in increased angiogenesis compared to moist wound therapy.

Conditions

Wounds

Keywords

Angiogenesis; Post surgical dehisced wounds of the lower extremity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

VAC® Therapy System DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KCI USA, Inc: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jeffrey A Niezgoda, M.D.

  St. Luke's Medical Center of Aurora Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 2, 2024

Record last verified: 2024-11