Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negatvie Pressure Wound Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT00847730
First received: February 17, 2009
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

The study is aimed at evaluating the clinician's preceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.


Condition Intervention Phase
Diabetic Foot Ulcers
Device: V.A.C. Negative Pressure Wound Therapy System
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Single Arm, Prospective Clinical Trial Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabectic Foot Ulcers Receiving VAC Negative Pressure Therapy

Resource links provided by NLM:


Further study details as provided by KCI USA, Inc.:

Primary Outcome Measures:
  • Percentage of subjects with satisfactory performace, defined as a cumulative eas of use score >6 and a munimum score of >2 on each indiviual charecteristic [ Time Frame: 48-72 hours (+6 hours) time period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with a score of >2 on the patient comfort during wear assessment [ Time Frame: 48-72 hours (+6 hrs) time period ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: V.A.C. Negative Pressure Wound Therapy System
    This is a non-invasive wound treatment system that uses controlled, localized negative pressure to create an enviroment that promotes wound healing in chronic and acute wounds
Detailed Description:

The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or Female subjects must be ≥ 18 years of age
  2. Subject is willing and able to provide written informed consent and comply with protocol required procedures
  3. Subject has a calcaneal, dorsal or plantar diabetic foot ulcer no greater than a Grade 2 on the Wagner Grading System for which ActiV.A.C.® Therapy has been prescribed and requires off loading of the SensaT.R.A.C. PadTM
  4. Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2
  5. Female subject that is willing to use an effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. Acceptable means of contraception is defined as use of Birth control pills, Depo Provera® , Norplant® , IUD (intrauterine device), Diaphragm with spermicide, Condom with spermicide

Exclusion Criteria

  1. Subject's wound measures > 84 cm2
  2. Presence of untreated cellulitis
  3. Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone)
  4. History of radiation to the wound area
  5. History of thermal injury in the wound area
  6. Known hypersensitivity to any disposable component of the V.A.C.® Therapy system
  7. Necrotic tissue with eschar present that cannot be debrided prior to subject enrollment in the study
  8. Subject is exhibiting active signs and symptoms of infection of the wound(i.e. increased redness or erythema, increased pain, warmth, purulent drainage)
  9. Past or current enrollment in this clinical study or any other clinical study within 30 days
  10. Female Subject who is pregnant or is unwilling to use acceptable means of contraception during the duration of her participation in the study
  11. Subject exhibits significant peri-wound issues that in the opinion of the investigator can interfere with the study assessments
  12. Subject is unable to co-operate with study assessments or has a history of non-compliance with off-loading modalities or has a foot deformity that in the opinion of the investigator does not allow for appropriate dressing application or off loading placement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847730

Locations
United States, Connecticut
North American Center for Limb Preservation
New Haven, Connecticut, United States, 06515
United States, Florida
Drs Research Network
S Miami, Florida, United States, 33143
United States, Pennsylvania
Key Stone Medical Research Associates
Bethlehem, Pennsylvania, United States, 18018
United States, Texas
Alamo Family Foot and Ankle Care
San Antonio, Texas, United States, 78258
Alamo Clinical Research Consultants
San Antonio, Texas, United States, 78212
Scott and White Dept of Surgery
Temple, Texas, United States, 76508
Sponsors and Collaborators
KCI USA, Inc.
  More Information

No publications provided

Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT00847730     History of Changes
Other Study ID Numbers: VACDrsg 2008-37
Study First Received: February 17, 2009
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by KCI USA, Inc.:
Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 16, 2014