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

NCT00847730 | Completed Results

• 1 other identifier: VACDrsg 2008-37
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetic Foot Ulcers

Keywords

Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  48-72 hours (+6 hours) time period

Study Arms (1)

VAC GranuFoam Bridge Dressing

EXPERIMENTAL

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

Interventions

V.A.C. Negative Pressure Wound Therapy System 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

VAC GranuFoam Bridge Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (6)

North American Center for Limb Preservation

New Haven, Connecticut, 06515, United States

Location

Drs Research Network

South Miami, Florida, 33143, United States

Location

Key Stone Medical Research Associates

Bethlehem, Pennsylvania, 18018, United States

Location

Alamo Clinical Research Consultants

San Antonio, Texas, 78212, United States

Location

Alamo Family Foot and Ankle Care

San Antonio, Texas, 78258, United States

Location

Scott and White Dept of Surgery

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: VP, Global Clinical Affairs
• Organization: KCI

jane.hart@kci1.com

2102555595

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 16, 2024
• Results First Posted: July 16, 2019

Record last verified: 2024-10

Locations

US (6)