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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01108276
• Other study ID #: 2010-071
• Status: Withdrawn
• Phase: Phase 4
• First received: April 20, 2010
• Last updated: March 8, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Foot Wound

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	ConvaTec Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall decrease in wound size	Overall decrease in wound size, summary statistics will be performed comparing both study groups.	12 weeks	No