Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy
Primary Purpose
Diabetes, Foot Wound
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Convatec engenex negative pressure wound therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Subject is 18 years of age or older
- Subjects with chronic lower extremity diabetic wounds, with or without a previous history of partial foot amputation.
- Subject has Diabetes Mellitus (type 1 or type 2)
- University of Texas Classification 1A-3A or 1B-3B
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Exclusion Criteria:
- Subjects < 18 years of age
- Subject is non-diabetic
- Subjects who present with wounds of etiology other than diabetes
- Subject demonstrates increased signs of clinical infection
- 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.
- University of Texas Classification 1C-3C
- Subjects participating in any other trials in regards to the diabetic foot ulcer.
Sites / Locations
Outcomes
Primary Outcome Measures
Overall decrease in wound size
Overall decrease in wound size, summary statistics will be performed comparing both study groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT01108276
First Posted
April 20, 2010
Last Updated
March 8, 2012
Sponsor
Georgetown University
Collaborators
ConvaTec Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01108276
Brief Title
Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started and therefore terminated.
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
ConvaTec Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Foot Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
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)
Convatec engenex negative pressure wound therapy
Other Intervention Name(s)
Convatec engenex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall decrease in wound size
Description
Overall decrease in wound size, summary statistics will be performed comparing both study groups.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is 18 years of age or older
Subjects with chronic lower extremity diabetic wounds, with or without a previous history of partial foot amputation.
Subject has Diabetes Mellitus (type 1 or type 2)
University of Texas Classification 1A-3A or 1B-3B
Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Exclusion Criteria:
Subjects < 18 years of age
Subject is non-diabetic
Subjects who present with wounds of etiology other than diabetes
Subject demonstrates increased signs of clinical infection
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.
University of Texas Classification 1C-3C
Subjects participating in any other trials in regards to the diabetic foot ulcer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Steinberg, DPM
Organizational Affiliation
Georgetown University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy
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