Clinical trial NCT00847730: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Ease of Use Assessment
timeFrame: 48-72 hours (+6 hours) time period
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: North American Center for Limb Preservation
state: Connecticut
city: South Miami
country: United States
facility: Drs Research Network
state: Florida
city: Bethlehem
country: United States
facility: Key Stone Medical Research Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: Alamo Clinical Research Consultants
state: Texas
city: San Antonio
country: United States
facility: Alamo Family Foot and Ankle Care
state: Texas
city: Temple
country: United States
facility: Scott and White Dept of Surgery
state: Texas
Study officials:
References: