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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Withdrawn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

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Withdrawn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

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

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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