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

NCT ID: NCT00847730

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-09-30

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.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

V.A.C. Negative Pressure Wound Therapy System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCI USA, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North American Center for Limb Preservation

New Haven, Connecticut, United States

Drs Research Network

South Miami, Florida, United States

Key Stone Medical Research Associates

Bethlehem, Pennsylvania, United States

Alamo Clinical Research Consultants

San Antonio, Texas, United States

Alamo Family Foot and Ankle Care

San Antonio, Texas, United States

Scott and White Dept of Surgery

Temple, Texas, United States

Countries

United States

Other Identifiers

VACDrsg 2008-37

Identifier Type: -

Identifier Source: org_study_id