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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847730
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : September 9, 2011
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: V.A.C. Negative Pressure Wound Therapy System Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage of subjects with a score of >2 on the patient comfort during wear assessment [ Time Frame: 48-72 hours (+6 hrs) time period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00847730

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 Clinical Research Consultants
San Antonio, Texas, United States, 78212
Alamo Family Foot and Ankle Care
San Antonio, Texas, United States, 78258
Scott and White Dept of Surgery
Temple, Texas, United States, 76508
Sponsors and Collaborators

Responsible Party: KCI USA, Inc. Identifier: NCT00847730     History of Changes
Other Study ID Numbers: VACDrsg 2008-37
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011

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