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

July 29, 2022 updated by: 3M

A Single Arm, Prospective Clinical Trial Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • North American Center for Limb Preservation
    • Florida
      • South Miami, Florida, United States, 33143
        • Drs Research Network
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18018
        • Key Stone Medical Research Associates
    • Texas
      • San Antonio, Texas, United States, 78212
        • Alamo Clinical Research Consultants
      • San Antonio, Texas, United States, 78258
        • Alamo Family Foot and Ankle Care
      • Temple, Texas, United States, 76508
        • Scott and White Dept of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VAC GranuFoam Bridge Dressing
This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
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 environment that promotes wound healing in chronic and acute wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Use Assessment
Time Frame: 48-72 hours (+6 hours) time period
Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.
48-72 hours (+6 hours) time period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VACDrsg 2008-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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