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

NCT01108276 | Withdrawn Phase 4

• 1 other identifier: 2010-071
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Foot Wound

Outcome Measures

Primary Outcomes (1)

• Overall decrease in wound size

  Overall decrease in wound size, summary statistics will be performed comparing both study groups.

  12 weeks

Interventions

Convatec engenex negative pressure wound therapy DEVICE

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.

Also known as: Convatec engenex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• ConvaTec Inc.: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Foot Injuries

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• John Steinberg, DPM

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 21, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03