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

NCT ID: NCT01108276

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Diabetes; Foot Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Convatec engenex

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

John Steinberg, DPM

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Steinberg, DPM

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Other Identifiers

2010-071

Identifier Type: -

Identifier Source: org_study_id