Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy

This study has been withdrawn prior to enrollment.
(Study never started and therefore terminated.)
Sponsor:
Collaborator:
ConvaTec Inc.
Information provided by (Responsible Party):
John Steinberg, DPM, Georgetown University
ClinicalTrials.gov Identifier:
NCT01108276
First received: April 20, 2010
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

This is an investigator-initiated prospective, randomized, controlled study. Hypothesis/Objective: The study will evaluate the rates of wound healing among patients with lower extremity diabetic wounds comparing two groups of patients. Group 1, the control group, will be treated with the standard of care treatment of moist wound therapy. Group 2 will be treated with ConvaTec Engenex® NPWT. Both groups will be treated in the inpatient and outpatient setting. It is expected that the NPWT device will be an effective therapy that expedites time to closure and demonstrates a significant decrease in the size and depth of the wound over the course of the 12 week therapy as compared to the standard of care.


Condition Intervention Phase
Diabetes
Foot Wound
Device: Convatec engenex negative pressure wound therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy (NPWT) Device to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Wounds

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Overall decrease in wound size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Overall decrease in wound size, summary statistics will be performed comparing both study groups.


Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Convatec engenex negative pressure wound therapy
    ConvaTec Engenex® is a negative pressure wound therapy that stimulates wound healing and promotes granulation tissue formation, removal of wound exudate and infectious materials by the application of negative pressure to wounds. It utilizes Bio-Dome™ Dressing technology to effectively control infection, drainage and odor while promoting granulation and wound healing at 75mmHg pressure.
    Other Name: Convatec engenex
Detailed Description:

After determining if you meet the criteria to be included in the study, your wound will be debrided (cleansed of any dead tissue or infection). You will then be randomly placed into one of two treatment groups. Group 1 will be the control group and a moist wound therapy will be applied to the wound. Either you or home nursing will then change the dressing twice a week. Group 2 will have a negative pressure wound therapy (NPWT) dressing applied. The NPWT dressing will be changed twice a week by home nursing. You will return to clinic every 2 weeks for a total of 12 weeks for observation and assessment of the diabetic foot ulcer. If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 18 years of age or older
  2. Subjects with chronic lower extremity diabetic wounds, with or without a previous history of partial foot amputation.
  3. Subject has Diabetes Mellitus (type 1 or type 2)
  4. University of Texas Classification 1A-3A or 1B-3B
  5. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria:

  1. Subjects < 18 years of age
  2. Subject is non-diabetic
  3. Subjects who present with wounds of etiology other than diabetes
  4. Subject demonstrates increased signs of clinical infection
  5. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
  6. University of Texas Classification 1C-3C
  7. Subjects participating in any other trials in regards to the diabetic foot ulcer.
  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: NCT01108276

Sponsors and Collaborators
Georgetown University
ConvaTec Inc.
Investigators
Principal Investigator: John Steinberg, DPM Georgetown University Hospital
  More Information

No publications provided

Responsible Party: John Steinberg, DPM, Associate Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01108276     History of Changes
Other Study ID Numbers: 2010-071
Study First Received: April 20, 2010
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 31, 2014