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

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
V.A.C. Negative Pressure Wound Therapy System
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Foot Ulcers focused on measuring Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North American Center for Limb Preservation
  • Drs Research Network
  • Key Stone Medical Research Associates
  • Alamo Clinical Research Consultants
  • Alamo Family Foot and Ankle Care
  • Scott and White Dept of Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VAC GranuFoam Bridge Dressing

Arm Description

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.

Outcomes

Primary Outcome Measures

Ease of Use Assessment
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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2009
Last Updated
July 29, 2022
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT00847730
Brief Title
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAC GranuFoam Bridge Dressing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
V.A.C. Negative Pressure Wound Therapy System
Intervention Description
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
Primary Outcome Measure Information:
Title
Ease of Use Assessment
Description
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.
Time Frame
48-72 hours (+6 hours) time period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male or Female subjects must be ≥ 18 years of age Subject is willing and able to provide written informed consent and comply with protocol required procedures 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 Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2 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 Subject's wound measures > 84 cm2 Presence of untreated cellulitis Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone) History of radiation to the wound area History of thermal injury in the wound area Known hypersensitivity to any disposable component of the V.A.C.® Therapy system Necrotic tissue with eschar present that cannot be debrided prior to subject enrollment in the study Subject is exhibiting active signs and symptoms of infection of the wound(i.e. increased redness or erythema, increased pain, warmth, purulent drainage) Past or current enrollment in this clinical study or any other clinical study within 30 days Female Subject who is pregnant or is unwilling to use acceptable means of contraception during the duration of her participation in the study Subject exhibits significant peri-wound issues that in the opinion of the investigator can interfere with the study assessments 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.
Facility Information:
Facility Name
North American Center for Limb Preservation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
Drs Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Key Stone Medical Research Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18018
Country
United States
Facility Name
Alamo Clinical Research Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Alamo Family Foot and Ankle Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Scott and White Dept of Surgery
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

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

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