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

NCT01108276 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-03-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ConvaTec Inc.

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • John Steinberg, DPM · Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-05-31
Completion
2011-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108276 on ClinicalTrials.gov